{"id":86189,"date":"2026-04-10T16:17:22","date_gmt":"2026-04-10T23:17:22","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=library&#038;p=86189"},"modified":"2026-04-10T16:29:44","modified_gmt":"2026-04-10T23:29:44","slug":"requirements-management-guide-medical-devices-gspr","status":"publish","type":"library","link":"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/gspr\/","title":{"rendered":"What Is General Safety and Performance Requirements (GSPR)? What You Need To Know"},"content":{"rendered":"<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt25zx8k-95cea1c5329117157a2b681b40296fe4\">\n.avia-section.av-kt25zx8k-95cea1c5329117157a2b681b40296fe4{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-header.png);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:0px;\nmargin-bottom:0px;\n}\n<\/style>\n<div id='requirements-management-header'  class='avia-section av-kt25zx8k-95cea1c5329117157a2b681b40296fe4 main_color avia-section-default avia-no-border-styling av-small-hide av-mini-hide avia-full-stretch avia-bg-style-scroll container_wrap sidebar_right'  data-section-bg-repeat='stretch'><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-86189'><div class='entry-content-wrapper clearfix'>\r\n<div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-individual'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt265h6u-d6a96dee24290389522c001709d22a48\">\n.flex_column.av-kt265h6u-d6a96dee24290389522c001709d22a48{\norder:0;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-kt265h6u-d6a96dee24290389522c001709d22a48 av_one_third first no_margin flex_column_div av-zero-column-padding avia-link-column av-column-link  '    data-link-column-url=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/\"   ><a class=\"av-screen-reader-only\" href=https:\/\/www.jamasoftware.com\/requirements-management-guide\/ >Follow a manual added link<\/a><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt261529-f74fbfeb09298a4be27cfcf51fc31861\">\n.avia-image-container.av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-kt261529-f74fbfeb09298a4be27cfcf51fc31861 av-styling- avia-align-right  right'  ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-56114 avia-img-lazy-loading-not-56114 avia_image ' src=\"https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-150x150.png\" alt='' title='requirements management guide icon'  height=\"150\" width=\"150\" srcset=\"https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-150x150.png 150w, https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-80x80.png 80w, https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon.png 272w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 --><div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-individual'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt2699f2-ecc685273939b22531502fbf4c623f6b\">\n.flex_column.av-kt2699f2-ecc685273939b22531502fbf4c623f6b{\norder:0;\npadding:0px 5% 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-kt2699f2-ecc685273939b22531502fbf4c623f6b av_one_half no_margin flex_column_div avia-link-column av-column-link  '    data-link-column-url=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/\"   ><a class=\"av-screen-reader-only\" href=https:\/\/www.jamasoftware.com\/requirements-management-guide\/ >Follow a manual added link<\/a><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a\">\n#top .av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kt268dsk-dff231d2c17cd08a1fbe9fb24cec861a av-special-heading-h1 custom-color-heading blockquote modern-quote  left'><h1 class='av-special-heading-tag '  ><em>The Essential Guide to <\/em>Requirements Management and Traceability<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 -->\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-86189'><div class='entry-content-wrapper clearfix'>\r\n\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef\">\n.avia-section.av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef{\nbackground-color:#7eda11;\nbackground:linear-gradient( to top right, #7eda11, #00adf6 );\nmargin-top:0px;\nmargin-bottom:0px;\n}\n<\/style>\n<div id='requirements-management-header'  class='avia-section av-lgcgdqtg-cdfa7b74eaee9379eaed9ee24a7812ef main_color avia-section-small avia-no-border-styling av-desktop-hide av-medium-hide 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src=\"https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-80x80.png\" alt='' title='requirements management guide icon'  height=\"80\" width=\"80\" srcset=\"https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-80x80.png 80w, https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon-150x150.png 150w, https:\/\/www.jamasoftware.com\/media\/2021\/09\/requirements-management-guide-icon.png 272w\" sizes=\"(max-width: 80px) 100vw, 80px\" \/><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgcgdhku-707c6db513aef4676f39272a4957b4f4\">\n#top .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:20px;\n}\nbody .av-special-heading.av-lgcgdhku-707c6db513aef4676f39272a4957b4f4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all 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av-special-heading-h1 custom-color-heading blockquote modern-quote  left av-inherit-size'><h1 class='av-special-heading-tag '  ><em>The Essential Guide to <\/em>Requirements Management and Traceability<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><\/div><!--close flex column wrapper. Autoclose: 1 -->\r\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-86189'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-layout-grid-1'  class='av-layout-grid-container av-kt271a4m-10bb91fdac7866deb9b459933dd30004 entry-content-wrapper main_color av-flex-cells  avia-builder-el-1  el_after_av_repeatable_content  avia-builder-el-last  container grid-row-not-first  container_wrap sidebar_right'  >\n<div class='flex_cell av-9ly1rq-d271f8801eb2a31a37348c33d9260025 av-gridrow-cell av_one_fourth no_margin  avia-builder-el-2  el_before_av_cell_three_fourth  avia-builder-el-first '  ><div class='flex_cell_inner'><div  class='flex_column av-kscxjq-ef7413936882eee52a8ce740328b4938 av_one_full  avia-builder-el-3  avia-builder-el-no-sibling  first flex_column_div  '     ><section  class='av_textblock_section av-kt27dbgd-69e0ca3c07a4090259a3a00cfabffb24 '  ><div class='avia_textblock' ><div id=\"chapter-menu\" class=\"expand\"><h6>Chapters<\/h6><div class=\"menu-container\"><ul>\n\t\t\t\t<li id=\"requirements-management\" class=\"expand \">\n\t\t\t\t<strong>1.<\/strong> Requirements Management\n\t\t\t\t<\/li><div id=\"requirements-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/requirements-management\/\"> What is Requirements Management? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-do-you-need-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/why-do-you-need-requirements-management\/\"> Why do you need Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-fundamentals-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/four-fundamentals-of-requirements-management\/\"> Four Stages of Requirements Management Processes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-an-agile-approach-to-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/adopting-an-agile-approach-to-requirements-management\/\"> Adopting an Agile Approach to Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"status-requests-changes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/status-requests-changes\/\"> Status Request Changes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"conquering-the-5-biggest-challenges-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/conquering-the-5-biggest-challenges-of-requirements-management\/\"> Conquering the 5 Biggest Challenges of Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"three-reasons-you-need-a-requirements-management-solution\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/three-reasons-you-need-a-requirements-management-solution\/\"> Three Reasons You Need a Requirements Management Solution<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\/\"> Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"writing-requirements\" class=\"expand \">\n\t\t\t\t<strong>2.<\/strong> Writing Requirements\n\t\t\t\t<\/li><div id=\"writing-requirements\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-requirements-examples-and-templates\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/functional-requirements-examples-and-templates\/\"> Functional requirements examples and templates<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/product-requirements-document\/\"> What Is a Product Requirements Document? A Complete PRD Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"identifying-and-measuring-the-quality-of-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/identifying-and-measuring-the-quality-of-requirements\/\"> Identifying and Measuring Requirements Quality<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"user-requirement-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/user-requirement-specification\/\"> What Is a User Requirement Specification (URS)? How to Write and Manage One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-requirements-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/system-requirements-specification\/\"> How to Write a System Requirements Specification (SRS) Document<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\/\"> The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-the-ears-notation-to-improve-requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/adopting-the-ears-notation-to-improve-requirements-engineering\/\"> Adopting the EARS Notation to Improve Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-risk-assessment\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/compliance-risk-assessment\/\"> What Is a Compliance Risk Assessment? Steps, Framework, and Examples<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"jama-connect-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/jama-connect-advisor\/\"> Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\/\"> Frequently Asked Questions about the EARS Notation and Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-write-an-effective-product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/how-to-write-an-effective-product-requirements-document\/\"> How to Write an Effective Product Requirements Document (PRD)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-vs-non-functional-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/functional-vs-non-functional-requirements\/\"> Functional vs. Non-Functional Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-non-functional-requirements-impact-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/how-non-functional-requirements-impact-product-development\/\"> What Are Nonfunctional Requirements and How Do They Impact Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-characteristics-of-excellent-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/the-characteristics-of-excellent-requirements\/\"> Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-design-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/software-design-specification\/\"> What Is a Software Design Specification? Key Components + Template<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"8-dos-and-donts-for-writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/8-dos-and-donts-for-writing-requirements\/\"> 8 Do\u2019s and Don\u2019ts for Writing Requirements<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"expand \">\n\t\t\t\t<strong>3.<\/strong> Requirements Gathering and Management Processes\n\t\t\t\t<\/li><div id=\"requirements-gathering-and-management-processes\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-engineering\/\"> Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-analysis\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-analysis\/\"> Requirements Analysis<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"a-guide-to-requirements-elicitation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/a-guide-to-requirements-elicitation-for-product-teams\/\"> A Guide to Requirements Elicitation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-gathering-techniques-for-agile-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-gathering-techniques-for-agile-product-teams\/\"> Requirements Gathering Techniques for Agile Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-requirements-gathering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/what-is-requirements-gathering\/\"> Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"defining-and-implementing-requirements-baselines\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/defining-and-implementing-requirements-baselines\/\"> Defining and Implementing a Requirements Baseline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"managing-project-scope-why-it-matters-and-best-practices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/managing-project-scope-why-it-matters-and-best-practices\/\"> Managing Project Scope \u2014 Why It Matters and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-long-do-requirements-take\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-long-do-requirements-take\/\"> How Long Do Requirements Take?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-reuse-requirements-across-multiple-products\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-to-reuse-requirements-across-multiple-products\/\"> How to Reuse Requirements Across Multiple Products<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-traceability\" class=\"expand \">\n\t\t\t\t<strong>4.<\/strong> Requirements Traceability\n\t\t\t\t<\/li><div id=\"requirements-traceability\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-is-traceability-achieved-a-practical-guide-for-engineers\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/how-is-traceability-achieved-a-practical-guide-for-engineers\/\"> How is Traceability Achieved? A Practical Guide for Engineers<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability\/\"> What is Requirements Traceability? Importance Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tracing-your-way-to-success\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/tracing-your-way-to-success\/\"> Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bidirectional-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/bidirectional-traceability\/\"> Bidirectional Traceability: What It Is and How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"engineering-change-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/engineering-change-management\/\"> What is Engineering Change Management (ECM)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"change-impact-analysis-cia-a-short-guide-for-effective-implementation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/reguirements-traceability\/change-impact-analysis-cia-a-short-guide-for-effective-implementation\/\"> Change Impact Analysis (CIA): A Short Guide for Effective Implementation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-5\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-5\/\"> What is Meant by Version Control?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-why-it-matters\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/requirements-traceability-why-it-matters\/\"> What is Requirements Traceability and Why Does It Matter for Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-7\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-7\/\"> Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-8\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-8\/\"> The Role of a Data Thread in Product and Software Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\/\"> Unraveling the Digital Thread: Enhancing Connectivity and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/traceability-matrix\/\"> What is a Traceability Matrix? A Guide to Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-create-and-use-a-requirements-traceability-matrix-rtm\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/how-to-create-and-use-a-requirements-traceability-matrix-rtm\/\"> How to Create and Use a Requirements Traceability Matrix (RTM)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-12\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-12\/\"> Traceability Matrix 101: Why It&#8217;s Not the Ultimate Solution for Managing Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-13\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-13\/\"> Live Traceability vs. After-the-Fact Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"overcoming-barriers-live-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/overcoming-barriers-live-traceability\/\"> Overcoming Barriers to Live Requirements Traceability\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-15\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-15\/\"> Requirements Traceability, What Are You Missing?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-best-practices-for-requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">18<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/four-best-practices-for-requirements-traceability\/\"> Four Best Practices for Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-links-in-the-chain\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">19<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/requirements-traceability-links-in-the-chain\/\"> Requirements Traceability: Links in the Chain<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-are-the-benefits-of-end-to-end-traceability-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">20<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-are-the-benefits-of-end-to-end-traceability-in-product-development\/\"> What Are the Benefits of End-to-End Traceability During Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-19-2\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">21<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-19-2\/\"> FAQs About Requirements Traceability<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"expand \">\n\t\t\t\t<strong>5.<\/strong> Requirements Management Tools and Software\n\t\t\t\t<\/li><div id=\"requirements-management-tools-and-software\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"selecting-the-right-requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/selecting-the-right-requirements-management-tools-and-software\/\"> Selecting the Right Requirements Management Tools and Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-investing-in-rm-software-makes-good-business-sense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/why-investing-in-rm-software-makes-good-business-sense\/\"> Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\/\"> Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-excel\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-excel\/\"> Can You Track Requirements in Excel?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"application-lifecycle-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/application-lifecycle-management\/\"> What Is Application Lifecycle Management (ALM)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"is-there-life-after-doors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/is-there-life-after-doors\/\"> Is There Life After DOORS\u00ae?\u00a0<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-jira\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-jira\/\"> Can You Track Requirements in Jira?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"checklist-selecting-a-requirements-management-tool\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/checklist-selecting-a-requirements-management-tool\/\"> Checklist: Selecting a Requirements Management Tool<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"expand \">\n\t\t\t\t<strong>6.<\/strong> Requirements Validation and Verification\n\t\t\t\t<\/li><div id=\"requirements-validation-and-verification\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-verification-and-validation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/requirements-verification-and-validation-for-product-teams\/\"> Requirements Verification and Validation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"best-practices-for-verification-and-validation-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/best-practices-for-verification-and-validation-in-product-development\/\"> Best Practices for Verification and Validation in Product Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-validation-and-traceability-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/requirements-validation-and-traceability-explained\/\"> Requirement Validation and Traceability Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-integration-testing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/system-integration-testing\/\"> What Is System Integration Testing (SIT)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand \">\n\t\t\t\t<strong>7.<\/strong> Meeting Regulatory Compliance and Industry Standards\n\t\t\t\t<\/li><div id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-standards\/\"> Understanding ISO Standards<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-iec-27001-a-guide-to-information-security-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-iec-27001-a-guide-to-information-security-management\/\"> Understanding ISO\/IEC 27001: A Guide to Information Security Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-devsecops-a-guide-to-building-secure-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/what-is-devsecops-a-guide-to-building-secure-software\/\"> What is DevSecOps? A Guide to Building Secure Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/compliance-management\/\"> Compliance Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fmea\/\"> What is FMEA? Failure Mode and Effects Analysis Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\/\"> T\u00dcV S\u00dcD: Ensuring Safety, Quality, and Sustainability Worldwide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"systems-engineering\" class=\"expand \">\n\t\t\t\t<strong>8.<\/strong> Systems Engineering\n\t\t\t\t<\/li><div id=\"systems-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/what-is-systems-engineering\/\"> What is Systems Engineering?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\/\"> How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-systems-engineering-body-of-knowledge-sebok\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/the-systems-engineering-body-of-knowledge-sebok\/\"> The Systems Engineering Body of Knowledge (SEBoK)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-mbse-model-based-systems-engineering-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/what-is-mbse-model-based-systems-engineering-explained\/\"> What is MBSE? Model-Based Systems Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-between-government-and-contractors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/digital-engineering-between-government-and-contractors\/\"> Digital Engineering Between Government and Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\/\"> Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"automotive-engineering\" class=\"expand \">\n\t\t\t\t<strong>9.<\/strong> Automotive Development\n\t\t\t\t<\/li><div id=\"automotive-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"automotive-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iatf-16949\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iatf-16949\/\"> Understanding IATF 16949: A Quick Guide to Automotive Quality Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-26262-and-recent-updates-ensuring-functional-safety-in-the-automotive-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/iso-26262-and-recent-updates-ensuring-functional-safety-in-the-automotive-industry\/\"> ISO 26262 and Recent Updates: Ensuring Functional Safety in the Automotive Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-automotive-safety-integrity-levels-asil\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/guide-to-automotive-safety-integrity-levels-asil\/\"> A Guide to Automotive Safety Integrity Levels (ASIL)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"sotif\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/sotif\/\"> What Is SOTIF? A Guide to ISO 21448 for ADAS Safety<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"medical-devices\" class=\"expand \">\n\t\t\t\t<strong>10.<\/strong> Medical Device &#038; Life Sciences Development\n\t\t\t\t<\/li><div id=\"medical-devices\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"medical-devices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-importance-of-benefit-risk-analysis-in-medical-device-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/the-importance-of-benefit-risk-analysis-in-medical-device-development\/\"> The Importance of Benefit-Risk Analysis in Medical Device Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-as-a-medical-device-revolutionizing-healthcare\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/software-as-a-medical-device-revolutionizing-healthcare\/\"> Software as a Medical Device: Revolutionizing Healthcare<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"design-history-file-dhf\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/design-history-file-dhf\/\"> What\u2019s a Design History File, and How Are DHFs Used by Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\/\"> Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device &#038; Life Sciences Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iso-13485\/\"> What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\/\"> What You Need to Know: ANSI\/AAMI SW96:2023 \u2014 Medical Device Security<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\/\"> ISO 13485 vs ISO 9001: Understanding the Differences and Synergies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62304\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iec-62304\/\"> What Is IEC 62304? A Guide to Medical Device Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dmr-definition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/dmr-definition\/\"> What Is a Device Master Record (DMR)? Definition and FDA Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\/\"> Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\/\"> Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"gspr\" class=\"active\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/gspr\/\"> What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"aerospace-and-defense\" class=\"expand \">\n\t\t\t\t<strong>11.<\/strong> Aerospace &#038; Defense Development\n\t\t\t\t<\/li><div id=\"aerospace-and-defense\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"aerospace-and-defense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"arp4754a-ed-79a-enhancing-safety-in-aviation-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/arp4754a-ed-79a-enhancing-safety-in-aviation-development\/\"> ARP4754A \/ ED-79A: Enhancing Safety in Aviation Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\/\"> Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-254\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/do-254\/\"> What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-178c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/do-178c\/\"> What Is DO-178C? A Complete Guide to Airborne Software Certification<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"expand \">\n\t\t\t\t<strong>12.<\/strong> Architecture, Engineering, and Construction (AEC industry) Development\n\t\t\t\t<\/li><div id=\"architecture-engineering-and-construction-aec-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-the-aec-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/what-is-the-aec-industry\/\"> What is the AEC Industry?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"expand \">\n\t\t\t\t<strong>13.<\/strong> Industrial Manufacturing &#038; Machinery, Automation &#038; Robotics, Consumer Electronics, and Energy\n\t\t\t\t<\/li><div id=\"industrial-manufacturing-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-safety-made-simple-a-guide-to-iec-61508-for-manufacturing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/functional-safety-made-simple-a-guide-to-iec-61508-for-manufacturing\/\"> Functional Safety Made Simple: A Guide to IEC 61508 for Manufacturing<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\/\"> Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62061-functional-safety-for-machinery-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/iec-62061-functional-safety-for-machinery-systems\/\"> IEC 62061 \u2013 Functional Safety for Machinery Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-10218-ensuring-safety-in-industrial-robotics\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/iso-10218-ensuring-safety-in-industrial-robotics\/\"> ISO 10218: Ensuring Safety in Industrial Robotics<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"semiconductor\" class=\"expand \">\n\t\t\t\t<strong>14.<\/strong> Semiconductor Development\n\t\t\t\t<\/li><div id=\"semiconductor\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"semiconductor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-chiplets-are-changing-the-game-in-tech-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/why-chiplets-are-changing-the-game-in-tech-innovation\/\"> Why Chiplets Are Changing the Game in Tech Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\/\"> Integrating Digital Engineering and the Digital Thread for Semiconductor Design<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"expand \">\n\t\t\t\t<strong>15.<\/strong> AI in Product Development\n\t\t\t\t<\/li><div id=\"artificial-intelligence-in-product-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/artificial-intelligence-in-product-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/artificial-intelligence-in-product-development\/artificial-intelligence-in-requirements-management\/\"> Artificial Intelligence in Requirements Management<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"risk-management\" class=\"expand \">\n\t\t\t\t<strong>16.<\/strong> Risk Management\n\t\t\t\t<\/li><div id=\"risk-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/failure-modes\/\"> What Are Failure Modes? Types, Examples, and How to Identify Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"types-of-fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/types-of-fmea\/\"> Types of FMEA: Definitions, Differences, and When to Use Each<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"expand \">\n\t\t\t\t<strong>17.<\/strong> Product Development Terms and Definitions\n\t\t\t\t<\/li><\/ul><div class=\"clear\"><\/div><\/div><\/div><p class=\"mobile-breadcrumb\"><span class=\"border\">Chapter 10<\/span>: What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/p><div class=\"mobile-menu\"><div id=\"chapter-menu\" class=\"expand\"><h6>Chapters<\/h6><div class=\"menu-container\"><ul>\n\t\t\t\t<li id=\"requirements-management\" class=\"expand \">\n\t\t\t\t<strong>1.<\/strong> Requirements Management\n\t\t\t\t<\/li><div id=\"requirements-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/requirements-management\/\"> What is Requirements Management? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-do-you-need-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/why-do-you-need-requirements-management\/\"> Why do you need Requirements Management?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-fundamentals-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/four-fundamentals-of-requirements-management\/\"> Four Stages of Requirements Management Processes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-an-agile-approach-to-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/adopting-an-agile-approach-to-requirements-management\/\"> Adopting an Agile Approach to Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"status-requests-changes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/status-requests-changes\/\"> Status Request Changes<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"conquering-the-5-biggest-challenges-of-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/conquering-the-5-biggest-challenges-of-requirements-management\/\"> Conquering the 5 Biggest Challenges of Requirements Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"three-reasons-you-need-a-requirements-management-solution\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/three-reasons-you-need-a-requirements-management-solution\/\"> Three Reasons You Need a Requirements Management Solution<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management\/guide-to-poor-requirements-identify-causes-repercussions-and-how-to-fix-them\/\"> Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"writing-requirements\" class=\"expand \">\n\t\t\t\t<strong>2.<\/strong> Writing Requirements\n\t\t\t\t<\/li><div id=\"writing-requirements\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-requirements-examples-and-templates\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/functional-requirements-examples-and-templates\/\"> Functional requirements examples and templates<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/product-requirements-document\/\"> What Is a Product Requirements Document? A Complete PRD Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"identifying-and-measuring-the-quality-of-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/identifying-and-measuring-the-quality-of-requirements\/\"> Identifying and Measuring Requirements Quality<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"user-requirement-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/user-requirement-specification\/\"> What Is a User Requirement Specification (URS)? How to Write and Manage One<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-requirements-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/system-requirements-specification\/\"> How to Write a System Requirements Specification (SRS) Document<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/the-fundamentals-of-business-requirements-examples-of-business-requirements-and-the-importance-of-excellence\/\"> The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"adopting-the-ears-notation-to-improve-requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/adopting-the-ears-notation-to-improve-requirements-engineering\/\"> Adopting the EARS Notation to Improve Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-risk-assessment\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/compliance-risk-assessment\/\"> What Is a Compliance Risk Assessment? Steps, Framework, and Examples<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"jama-connect-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/jama-connect-advisor\/\"> Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/frequently-asked-questions-about-the-ears-notation-and-jama-connect-requirements-advisor\/\"> Frequently Asked Questions about the EARS Notation and Jama Connect Advisor\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-write-an-effective-product-requirements-document\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/how-to-write-an-effective-product-requirements-document\/\"> How to Write an Effective Product Requirements Document (PRD)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-vs-non-functional-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/functional-vs-non-functional-requirements\/\"> Functional vs. Non-Functional Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-non-functional-requirements-impact-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/how-non-functional-requirements-impact-product-development\/\"> What Are Nonfunctional Requirements and How Do They Impact Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-characteristics-of-excellent-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/the-characteristics-of-excellent-requirements\/\"> Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-design-specification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/software-design-specification\/\"> What Is a Software Design Specification? Key Components + Template<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"8-dos-and-donts-for-writing-requirements\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/writing-requirements\/8-dos-and-donts-for-writing-requirements\/\"> 8 Do\u2019s and Don\u2019ts for Writing Requirements<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"expand \">\n\t\t\t\t<strong>3.<\/strong> Requirements Gathering and Management Processes\n\t\t\t\t<\/li><div id=\"requirements-gathering-and-management-processes\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-gathering-and-management-processes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-engineering\/\"> Requirements Engineering<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-analysis\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-analysis\/\"> Requirements Analysis<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"a-guide-to-requirements-elicitation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/a-guide-to-requirements-elicitation-for-product-teams\/\"> A Guide to Requirements Elicitation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-gathering-techniques-for-agile-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/requirements-gathering-techniques-for-agile-product-teams\/\"> Requirements Gathering Techniques for Agile Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-requirements-gathering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/what-is-requirements-gathering\/\"> Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"defining-and-implementing-requirements-baselines\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/defining-and-implementing-requirements-baselines\/\"> Defining and Implementing a Requirements Baseline<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"managing-project-scope-why-it-matters-and-best-practices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/managing-project-scope-why-it-matters-and-best-practices\/\"> Managing Project Scope \u2014 Why It Matters and Best Practices<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-long-do-requirements-take\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-long-do-requirements-take\/\"> How Long Do Requirements Take?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-reuse-requirements-across-multiple-products\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-gathering-and-management-processes\/how-to-reuse-requirements-across-multiple-products\/\"> How to Reuse Requirements Across Multiple Products<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-traceability\" class=\"expand \">\n\t\t\t\t<strong>4.<\/strong> Requirements Traceability\n\t\t\t\t<\/li><div id=\"requirements-traceability\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-is-traceability-achieved-a-practical-guide-for-engineers\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/how-is-traceability-achieved-a-practical-guide-for-engineers\/\"> How is Traceability Achieved? A Practical Guide for Engineers<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability\/\"> What is Requirements Traceability? Importance Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tracing-your-way-to-success\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/tracing-your-way-to-success\/\"> Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"bidirectional-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/bidirectional-traceability\/\"> Bidirectional Traceability: What It Is and How to Implement It<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"engineering-change-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/engineering-change-management\/\"> What is Engineering Change Management (ECM)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"change-impact-analysis-cia-a-short-guide-for-effective-implementation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/reguirements-traceability\/change-impact-analysis-cia-a-short-guide-for-effective-implementation\/\"> Change Impact Analysis (CIA): A Short Guide for Effective Implementation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-5\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-5\/\"> What is Meant by Version Control?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-why-it-matters\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/requirements-traceability-why-it-matters\/\"> What is Requirements Traceability and Why Does It Matter for Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-7\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-7\/\"> Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-8\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-8\/\"> The Role of a Data Thread in Product and Software Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/unraveling-the-digital-thread-enhancing-connectivity-and-efficiency\/\"> Unraveling the Digital Thread: Enhancing Connectivity and Efficiency<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"traceability-matrix\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/traceability-matrix\/\"> What is a Traceability Matrix? A Guide to Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-to-create-and-use-a-requirements-traceability-matrix-rtm\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">13<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/how-to-create-and-use-a-requirements-traceability-matrix-rtm\/\"> How to Create and Use a Requirements Traceability Matrix (RTM)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-12\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">14<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-12\/\"> Traceability Matrix 101: Why It&#8217;s Not the Ultimate Solution for Managing Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-13\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">15<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-13\/\"> Live Traceability vs. After-the-Fact Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"overcoming-barriers-live-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">16<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/overcoming-barriers-live-traceability\/\"> Overcoming Barriers to Live Requirements Traceability\u2122<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-15\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">17<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-15\/\"> Requirements Traceability, What Are You Missing?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"four-best-practices-for-requirements-traceability\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">18<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/four-best-practices-for-requirements-traceability\/\"> Four Best Practices for Requirements Traceability<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-traceability-links-in-the-chain\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">19<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/requirements-traceability-links-in-the-chain\/\"> Requirements Traceability: Links in the Chain<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-are-the-benefits-of-end-to-end-traceability-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">20<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-are-the-benefits-of-end-to-end-traceability-in-product-development\/\"> What Are the Benefits of End-to-End Traceability During Product Development?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-traceability-19-2\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">21<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/what-is-traceability-19-2\/\"> FAQs About Requirements Traceability<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"expand \">\n\t\t\t\t<strong>5.<\/strong> Requirements Management Tools and Software\n\t\t\t\t<\/li><div id=\"requirements-management-tools-and-software\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"selecting-the-right-requirements-management-tools-and-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/selecting-the-right-requirements-management-tools-and-software\/\"> Selecting the Right Requirements Management Tools and Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-investing-in-rm-software-makes-good-business-sense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/why-investing-in-rm-software-makes-good-business-sense\/\"> Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/why-word-and-excel-alone-is-not-enough-for-product-software-and-systems-development\/\"> Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-excel\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-excel\/\"> Can You Track Requirements in Excel?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"application-lifecycle-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/application-lifecycle-management\/\"> What Is Application Lifecycle Management (ALM)?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"is-there-life-after-doors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/is-there-life-after-doors\/\"> Is There Life After DOORS\u00ae?\u00a0<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"can-you-track-requirements-in-jira\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/can-you-track-requirements-in-jira\/\"> Can You Track Requirements in Jira?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"checklist-selecting-a-requirements-management-tool\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-management-tools-and-software\/checklist-selecting-a-requirements-management-tool\/\"> Checklist: Selecting a Requirements Management Tool<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"expand \">\n\t\t\t\t<strong>6.<\/strong> Requirements Validation and Verification\n\t\t\t\t<\/li><div id=\"requirements-validation-and-verification\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"requirements-validation-and-verification\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-verification-and-validation-for-product-teams\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/requirements-verification-and-validation-for-product-teams\/\"> Requirements Verification and Validation for Product Teams<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"best-practices-for-verification-and-validation-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/best-practices-for-verification-and-validation-in-product-development\/\"> Best Practices for Verification and Validation in Product Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"requirements-validation-and-traceability-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/requirements-validation-and-traceability-explained\/\"> Requirement Validation and Traceability Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"system-integration-testing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-validation-and-verification\/system-integration-testing\/\"> What Is System Integration Testing (SIT)? A Complete Guide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand \">\n\t\t\t\t<strong>7.<\/strong> Meeting Regulatory Compliance and Industry Standards\n\t\t\t\t<\/li><div id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"meeting-regulatory-compliance-and-industry-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-standards\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-standards\/\"> Understanding ISO Standards<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-iec-27001-a-guide-to-information-security-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/understanding-iso-iec-27001-a-guide-to-information-security-management\/\"> Understanding ISO\/IEC 27001: A Guide to Information Security Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-devsecops-a-guide-to-building-secure-software\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/what-is-devsecops-a-guide-to-building-secure-software\/\"> What is DevSecOps? A Guide to Building Secure Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"compliance-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/compliance-management\/\"> Compliance Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/fmea\/\"> What is FMEA? Failure Mode and Effects Analysis Guide<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/tuv-sud-ensuring-safety-quality-and-sustainability-worldwide\/\"> T\u00dcV S\u00dcD: Ensuring Safety, Quality, and Sustainability Worldwide<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"systems-engineering\" class=\"expand \">\n\t\t\t\t<strong>8.<\/strong> Systems Engineering\n\t\t\t\t<\/li><div id=\"systems-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-systems-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/what-is-systems-engineering\/\"> What is Systems Engineering?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/how-do-engineers-collaborate-a-guide-to-streamlined-teamwork-and-innovation\/\"> How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-systems-engineering-body-of-knowledge-sebok\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/the-systems-engineering-body-of-knowledge-sebok\/\"> The Systems Engineering Body of Knowledge (SEBoK)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-mbse-model-based-systems-engineering-explained\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/what-is-mbse-model-based-systems-engineering-explained\/\"> What is MBSE? Model-Based Systems Engineering Explained<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-between-government-and-contractors\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/digital-engineering-between-government-and-contractors\/\"> Digital Engineering Between Government and Contractors<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/systems-engineering\/digital-engineering-tools-the-key-to-driving-innovation-and-efficiency-in-complex-systems\/\"> Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"automotive-engineering\" class=\"expand \">\n\t\t\t\t<strong>9.<\/strong> Automotive Development\n\t\t\t\t<\/li><div id=\"automotive-engineering\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"automotive-engineering\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iatf-16949\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/meeting-regulatory-compliance-and-industry-standards\/iatf-16949\/\"> Understanding IATF 16949: A Quick Guide to Automotive Quality Management<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-26262-and-recent-updates-ensuring-functional-safety-in-the-automotive-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/iso-26262-and-recent-updates-ensuring-functional-safety-in-the-automotive-industry\/\"> ISO 26262 and Recent Updates: Ensuring Functional Safety in the Automotive Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"guide-to-automotive-safety-integrity-levels-asil\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/guide-to-automotive-safety-integrity-levels-asil\/\"> A Guide to Automotive Safety Integrity Levels (ASIL)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"sotif\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/automotive-engineering\/sotif\/\"> What Is SOTIF? A Guide to ISO 21448 for ADAS Safety<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"medical-devices\" class=\"expand \">\n\t\t\t\t<strong>10.<\/strong> Medical Device &#038; Life Sciences Development\n\t\t\t\t<\/li><div id=\"medical-devices\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"medical-devices\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"the-importance-of-benefit-risk-analysis-in-medical-device-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/the-importance-of-benefit-risk-analysis-in-medical-device-development\/\"> The Importance of Benefit-Risk Analysis in Medical Device Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"software-as-a-medical-device-revolutionizing-healthcare\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/software-as-a-medical-device-revolutionizing-healthcare\/\"> Software as a Medical Device: Revolutionizing Healthcare<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"design-history-file-dhf\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/design-history-file-dhf\/\"> What\u2019s a Design History File, and How Are DHFs Used by Product Teams?<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/navigating-the-risks-of-software-of-unknown-pedigree-soup-in-the-medical-device-and-life-sciences-industry\/\"> Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device &#038; Life Sciences Industry<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">5<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iso-13485\/\"> What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">6<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/what-you-need-to-know-ansi-aami-sw96-2023-medical-device-security\/\"> What You Need to Know: ANSI\/AAMI SW96:2023 \u2014 Medical Device Security<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">7<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iso-13485-vs-iso-9001-understanding-the-differences-and-synergies\/\"> ISO 13485 vs ISO 9001: Understanding the Differences and Synergies<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62304\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">8<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/iec-62304\/\"> What Is IEC 62304? A Guide to Medical Device Software<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"dmr-definition\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">9<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/dmr-definition\/\"> What Is a Device Master Record (DMR)? Definition and FDA Requirements<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">10<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/failure-modes-effects-and-diagnositc-analysis-fmeda-for-medical-devices-what-you-need-to-know\/\"> Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">11<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/embracing-the-future-of-healthcare-exploring-the-internet-of-medical-things-iomt\/\"> Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"gspr\" class=\"active\">\n\t\t\t\t\t\t<span class=\"border\">12<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/medical-devices\/gspr\/\"> What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"aerospace-and-defense\" class=\"expand \">\n\t\t\t\t<strong>11.<\/strong> Aerospace &#038; Defense Development\n\t\t\t\t<\/li><div id=\"aerospace-and-defense\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"aerospace-and-defense\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"arp4754a-ed-79a-enhancing-safety-in-aviation-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/arp4754a-ed-79a-enhancing-safety-in-aviation-development\/\"> ARP4754A \/ ED-79A: Enhancing Safety in Aviation Development<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/understanding-arp4761a-guidelines-for-system-safety-assessment-in-aerospace\/\"> Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-254\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/do-254\/\"> What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"do-178c\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/aerospace-and-defense\/do-178c\/\"> What Is DO-178C? A Complete Guide to Airborne Software Certification<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"expand \">\n\t\t\t\t<strong>12.<\/strong> Architecture, Engineering, and Construction (AEC industry) Development\n\t\t\t\t<\/li><div id=\"architecture-engineering-and-construction-aec-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"architecture-engineering-and-construction-aec-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"what-is-the-aec-industry\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/architecture-engineering-and-construction-aec-development\/what-is-the-aec-industry\/\"> What is the AEC Industry?<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"expand \">\n\t\t\t\t<strong>13.<\/strong> Industrial Manufacturing &#038; Machinery, Automation &#038; Robotics, Consumer Electronics, and Energy\n\t\t\t\t<\/li><div id=\"industrial-manufacturing-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"industrial-manufacturing-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"functional-safety-made-simple-a-guide-to-iec-61508-for-manufacturing\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/functional-safety-made-simple-a-guide-to-iec-61508-for-manufacturing\/\"> Functional Safety Made Simple: A Guide to IEC 61508 for Manufacturing<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/understanding-iso-13849-the-foundation-of-functional-safety-in-the-machinery-sector\/\"> Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iec-62061-functional-safety-for-machinery-systems\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">3<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/iec-62061-functional-safety-for-machinery-systems\/\"> IEC 62061 \u2013 Functional Safety for Machinery Systems<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"iso-10218-ensuring-safety-in-industrial-robotics\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">4<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/industrial-manufacturing-development\/iso-10218-ensuring-safety-in-industrial-robotics\/\"> ISO 10218: Ensuring Safety in Industrial Robotics<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"semiconductor\" class=\"expand \">\n\t\t\t\t<strong>14.<\/strong> Semiconductor Development\n\t\t\t\t<\/li><div id=\"semiconductor\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"semiconductor\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"why-chiplets-are-changing-the-game-in-tech-innovation\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/why-chiplets-are-changing-the-game-in-tech-innovation\/\"> Why Chiplets Are Changing the Game in Tech Innovation<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/semiconductor\/integrating-digital-engineering-and-the-digital-thread-for-semiconductor-design\/\"> Integrating Digital Engineering and the Digital Thread for Semiconductor Design<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"expand \">\n\t\t\t\t<strong>15.<\/strong> AI in Product Development\n\t\t\t\t<\/li><div id=\"artificial-intelligence-in-product-development\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-product-development\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/artificial-intelligence-in-product-development\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"artificial-intelligence-in-requirements-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/artificial-intelligence-in-product-development\/artificial-intelligence-in-requirements-management\/\"> Artificial Intelligence in Requirements Management<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"risk-management\" class=\"expand \">\n\t\t\t\t<strong>16.<\/strong> Risk Management\n\t\t\t\t<\/li><div id=\"risk-management\" class=\"expand-list\" style=\"display:none;\"><ul>\n\t\t\t\t\t<li id=\"risk-management\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\"><\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/\">Overview<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"failure-modes\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">1<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/failure-modes\/\"> What Are Failure Modes? Types, Examples, and How to Identify Them<\/a>\n\t\t\t\t\t<\/li>\n\t\t\t\t\t<li id=\"types-of-fmea\" class=\"\">\n\t\t\t\t\t\t<span class=\"border\">2<\/span>\n\t\t\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/types-of-fmea\/\"> Types of FMEA: Definitions, Differences, and When to Use Each<\/a>\n\t\t\t\t\t<\/li><\/ul><\/div>\n\t\t\t\t<li id=\"product-development-terms-and-definitions\" class=\"expand \">\n\t\t\t\t<strong>17.<\/strong> Product Development Terms and Definitions\n\t\t\t\t<\/li><\/ul><div class=\"clear\"><\/div><\/div><\/div><\/div>\n<\/div><\/section><\/div>\n<\/div><\/div><div class='flex_cell av-1vxh1fa-162c0e8fab30caffb39fc6a716745c9c av-gridrow-cell av_three_fourth no_margin'  ><div class='flex_cell_inner'><p><div  class='flex_column av-6bv6cfe-0bca5ea9eb71366ffef3ca20d8dcdefa av_one_full first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mnowyy8b-ca982bb9417e7f25f425b17618113255\">\n#top .av_textblock_section.av-mnowyy8b-ca982bb9417e7f25f425b17618113255 .avia_textblock{\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-mnowyy8b-ca982bb9417e7f25f425b17618113255 '  ><div class='avia_textblock av_inherit_color' ><h2>What Is General Safety and Performance Requirements (GSPR)? What You Need To Know<\/h2>\n<p>A well-structured GSPR checklist can make the difference between a smooth audit and weeks of scrambling to rebuild evidence chains. Most teams get the initial checklist right. The hard part is keeping it current as the device changes, standards get updated, and post-market data rolls in.<\/p>\n<p>This guide covers what GSPR is, how Annex I is structured, what auditors expect, and where documentation typically breaks down.<\/p>\n<h2>What Is General Safety and Performance Requirements (GSPR)?<\/h2>\n<p>General Safety and Performance Requirements (GSPR) are the legal obligations your medical device must satisfy to be placed on the EU market under the Medical Device Regulation (MDR) 2017\/745 or the In Vitro Diagnostic Regulation (IVDR) 2017\/746.<\/p>\n<p>A GSPR defines the outcome your device must deliver. A harmonized standard is one way to prove you meet that outcome. The regulation itself makes this distinction clear. Devices must comply with the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0745\" target=\"_blank\" rel=\"noopener\">safety and performance requirements<\/a> of the applicable legislation, not necessarily with the clauses of a specific standard.<\/p>\n<p>Teams sometimes treat harmonized standards as the requirement itself. When that happens, the GSPR checklist ends up mapping to standards instead of mapping standards back to legal obligations, and auditors notice.<\/p>\n<h2>Where Do GSPRs Live in the Regulation?<\/h2>\n<p>When an auditor asks where your conformity claim is grounded, the answer starts in Annex I. Both the MDR and IVDR require devices to comply with the GSPR set out there. For in vitro diagnostics, Article 56 of the IVDR governs the performance evaluation process.<\/p>\n<p>The technical documentation needed to demonstrate conformity is described in Annex II, Section 4. Most teams organize this as a GSPR checklist that includes:<\/p>\n<ul>\n<li><strong>Applicable GSPRs:<\/strong> Which requirements apply to your device, and why others do not.<\/li>\n<li><strong>Conformity methods:<\/strong> How you demonstrate conformity with each requirement.<\/li>\n<li><strong>Standards applied:<\/strong> Which harmonized standards or Common Specifications you used.<\/li>\n<li><strong>Document references:<\/strong> The specific controlled documents and their locations in your technical file.<\/li>\n<\/ul>\n<p>That last item, the cross-reference to specific document locations, is where traceability usually starts to break. A general pointer to &#8220;the risk management file&#8221; is not enough. Auditors expect a specific document, version, and location within that document for each GSPR row.<\/p>\n<h2>What Changed From Essential Requirements to GSPR?<\/h2>\n<p>Before the MDR, these obligations were called Essential Requirements (ERs) under the older Medical Device Directive (MDD). The MDR replaced that framework with GSPR, and the change was more than a rename.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-large wp-image-86191\" src=\"https:\/\/www.jamasoftware.com\/media\/2026\/04\/Where-Do-GSPRs-Live-in-the-Regulation-1030x703.png\" alt=\"Where Do GSPRs Live in the Regulation Chart\" width=\"1030\" height=\"703\" srcset=\"https:\/\/www.jamasoftware.com\/media\/2026\/04\/Where-Do-GSPRs-Live-in-the-Regulation-1030x703.png 1030w, https:\/\/www.jamasoftware.com\/media\/2026\/04\/Where-Do-GSPRs-Live-in-the-Regulation-300x205.png 300w, https:\/\/www.jamasoftware.com\/media\/2026\/04\/Where-Do-GSPRs-Live-in-the-Regulation.png 1268w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/p>\n<p>The biggest practical change is the &#8220;state of the art&#8221; obligation in Section 1. Your device must be designed and manufactured using what the industry currently considers current practice. That means your GSPR checklist has to reflect the latest applicable standards, even if those have changed since your original certification.<\/p>\n<h2>The Three Chapters of GSPR in Annex I<\/h2>\n<p>Annex I of the MDR is organized into three chapters covering 23 sections. Chapters I and III apply broadly to medical devices. Chapter II depends on your device&#8217;s specific characteristics, and you need to document why any section does not apply.<\/p>\n<h3>Chapter I: General Safety and Performance (Sections 1-9)<\/h3>\n<p>These sections set the baseline for your safety argument. Devices must be safe and effective, with residual risks acceptable when weighed against patient benefits. Section 8 covers risk management, requiring that all known and foreseeable risks be minimized and acceptable relative to the device&#8217;s benefits. <a href=\"https:\/\/www.iso.org\/standard\/72704.html\" target=\"_blank\" rel=\"noopener\">ISO 14971:2019<\/a> is the standard most teams use for this section.<\/p>\n<h3>Chapter II: Device-Specific Requirements (Sections 10-22)<\/h3>\n<p>These sections map to your device&#8217;s physical, chemical, biological, and software characteristics. If your device includes software, Section 17 is where traceability requirements increase. It maps to IEC 62304 for software lifecycle processes and introduces cybersecurity requirements under Section 17.2 that had no explicit equivalent under the MDD. Section 18.8 adds a related requirement for devices to be designed against unauthorized access that could interfere with intended function.<\/p>\n<h3>Chapter III: Labeling and Instructions for Use (Section 23)<\/h3>\n<p>Section 23 has four subparts, not three. Teams sometimes miss Section 23.3 and end up with incomplete traceability in their GSPR checklist. Auditors expect each subpart of Section 23 to be traced separately, with specific justification for any subpart marked as not applicable.<\/p>\n<h2>What You Need To Demonstrate for GSPR Conformity<\/h2>\n<p>Building the checklist is the easy part. Keeping the evidence current as the device and its standards evolve is where teams get stuck. The MDR requires continuous compliance, so your technical documentation has to reflect the current state of the device throughout its entire market life.<\/p>\n<h3>Your Risk File Has To Cover the Full Lifecycle<\/h3>\n<p>ISO 14971:2019 follows the device from design through production and post-production. Your risk management file pulls together the plan, analysis, control measures, benefit-risk determination, and final report.<\/p>\n<p>What makes the MDR different from the older directive is the mandatory feedback loop. Post-market surveillance (PMS) data feeds into the clinical evaluation report, which feeds into the risk management file, which feeds back into your GSPR conformity claims. If one of those links breaks, the whole argument weakens.<\/p>\n<h3>Clinical Evidence Has To Map Back To Specific GSPRs<\/h3>\n<p>Article 61(1) of the MDR requires clinical data to support Sections 1 and 8 of Annex I at minimum. Your Clinical Evaluation Plan must identify which specific GSPRs need clinical evidence.<\/p>\n<p>For Class III and implantable devices, the post-market clinical follow-up report and Summary of Safety and Clinical Performance must be updated at least annually. The connection between clinical data and specific GSPR rows needs to stay valid through every report cycle, including years after the original filing.<\/p>\n<h3>PMS Has To Feed Back Directly Into GSPR Conformity<\/h3>\n<p>Your PMS system runs continuously. The MDR requires it to actively gather, record, and analyze data on your device&#8217;s quality, performance, and safety throughout its lifetime. Class IIa through III devices require Periodic Safety Update Reports (PSURs) that cover:<\/p>\n<ul>\n<li><strong>Benefit-risk conclusions:<\/strong> Current conclusions on the benefit-risk determination.<\/li>\n<li><strong>Post-market clinical follow-up findings:<\/strong> Key findings from ongoing clinical follow-up.<\/li>\n<li><strong>Corrective actions:<\/strong> Any preventive or corrective actions taken.<\/li>\n<\/ul>\n<p>A PSUR finding that shifts the benefit-risk profile may require updating the evidence behind specific GSPR rows. That makes the update cycle a traceability event, not a routine reporting exercise.<\/p>\n<h2>How GSPR Connects to Product Traceability<\/h2>\n<p>The traceability challenge with GSPR is a scale problem. Each checklist row needs cross-references to specific controlled documents, and that multiplies across product families, design changes, and standard transitions.<\/p>\n<p>The <a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/requirements-traceability\/bidirectional-traceability\/\" target=\"_blank\" rel=\"noopener\">bidirectional traceability<\/a> chain that auditors expect runs from user needs through design inputs, design outputs, and verification and validation evidence, down to specific GSPR rows and the standards used as evidence. Each row needs a specific evidence reference, not a vague file-level citation.<\/p>\n<p>In practice, the problem is whether a change upstream is visible everywhere downstream before the next audit. When an upstream requirement changes, every downstream artifact needs to be flagged for review.<\/p>\n<p><a href=\"https:\/\/www.jamasoftware.com\/\" target=\"_blank\" rel=\"noopener\">Jama Connect\u00ae<\/a> is a requirements management and traceability platform built for regulated industries. Its pre-built medical device framework keeps design controls, <a href=\"https:\/\/www.jamasoftware.com\/solutions\/risk-management\/\" target=\"_blank\" rel=\"noopener\">risk traceability<\/a>, and verification evidence connected in a single platform, so documentation reflects live data instead of manual assembly.<\/p>\n<h2>Where GSPR Documentation Breaks Down<\/h2>\n<p>Most documentation gaps are not caused by missing records. They come from documentation that was complete at one point but fell out of sync with the current device, the evidence, or the standards it references.<\/p>\n<h3>When Static Documents Fall Behind the Device<\/h3>\n<p>The typical failure mode is a GSPR checklist that was accurate at initial certification but has not kept pace with changes. A material change, a software update, or a manufacturing process modification each affects different GSPR sections. Unless your change control procedure explicitly triggers a GSPR impact assessment, the checklist goes stale. Outdated verification and validation documentation is one of the first gaps auditors surface during submission review.<\/p>\n<h3>When Standards Get Superseded<\/h3>\n<p>Standard transitions create a cascading update problem. When a harmonized standard is withdrawn or replaced, every GSPR checklist entry that references it needs to be identified, the gap between old and new versions analyzed, and the evidence cross-references updated. For teams with multiple devices on the market, that means finding the affected reference in every GSPR row, for every device.<\/p>\n<p>The state-of-the-art obligation adds another layer. Even when you are using a current harmonized standard, if a newer version represents current practice, you may need to justify continued use of the older version.<\/p>\n<h2>Building GSPR Compliance That Survives Audits<\/h2>\n<p>The shift from MDD to MDR is a structural change in how you demonstrate and maintain conformity. <a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/\" target=\"_blank\" rel=\"noopener\">Risk management<\/a> feeds clinical evaluation, which feeds post-market surveillance, which feeds back into the GSPR checklist. Every link in that chain needs to stay current and auditable.<\/p>\n<p>Jama Connect supports this continuous conformity workflow by keeping design controls, risk files, and GSPR evidence connected to live project data as the device and its regulatory context evolve. <a href=\"https:\/\/www.jamasoftware.com\/platform\/jama-connect\/trial\/?utm_campaign=cta+blog\" target=\"_blank\" rel=\"noopener\">Start a free 30-day trial<\/a> and see how the framework fits your team&#8217;s conformity workflow.<\/p>\n<h2>Frequently Asked Questions About GSPR<\/h2>\n<h3>What is a GSPR checklist under EU MDR?<\/h3>\n<p>A GSPR checklist is the Annex I conformity matrix in your technical documentation. It identifies which GSPRs apply, describes the methods used to demonstrate conformity, lists the standards applied, and provides references to the specific controlled documents that contain the evidence.<\/p>\n<h3>Why do auditors find gaps in GSPR documentation?<\/h3>\n<p>The documentation usually existed at some point. The checklist, evidence references, and standards citations just fell out of sync over time as the device went through design changes or standard transitions.\u00a0Static documents make that drift hard to detect until an auditor starts tracing evidence chains.<\/p>\n<h3>What kind of evidence should each GSPR row reference?<\/h3>\n<p>Each row needs a specific controlled document reference and its location in the technical file. Pointing to a general file like the risk management folder is not enough. Each row must identify the specific document, its version, and where within that document the evidence can be found.<\/p>\n<h3>When should a GSPR checklist be updated?<\/h3>\n<p>The checklist needs updating when standards are withdrawn or replaced, when design or intended-purpose changes occur, when new clinical or performance data changes the evidence base, or when post-market findings affect the benefit-risk profile. Any change that touches the controlled documents referenced in a GSPR row should trigger a review of that row&#8217;s evidence chain.<\/p>\n<\/div><\/section><\/div><section  class='av_textblock_section av-kt272dwm-d42d3d376d99045ff6cfafa99fec44da '  ><div class='avia_textblock' ><div class=\"flex_column_table av-equal-height-column-flextable\"><div class=\"flex_column av_one_half flex_column_div first previous\">\n\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/types-of-fmea\/\" class=\"\"><div class=\"arrow\"><a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/types-of-fmea\/\" class=\"\">PREVIOUS<\/a>\n\t\t\t\t<a href=\"https:\/\/www.jamasoftware.com\/requirements-management-guide\/risk-management\/types-of-fmea\/\" class=\"\"><span class=\"title\">Types of FMEA: Definitions, Differences, and When to Use Each<\/span><\/a><\/div>\n\t\t\t<\/div><\/div><div id=\"form\" class=\"cta-background flex_column_table av-equal-height-column-flextable\"><div class='av-column-wrapper-individual av-mobile-columns-flex av-columns-reverse'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m4auxxrv-ed813687835a92784865e29ca937fa69\">\n.flex_column.av-m4auxxrv-ed813687835a92784865e29ca937fa69{\nwidth:59.2%;\nborder-radius:8px 8px 8px 8px;\npadding:20px 20px 20px 20px;\nbackground-color:#f8fbff;\nbackground:linear-gradient( to bottom, #f8fbff, #fafbfd );\n}\n<\/style>\n<div  class='flex_column av-m4auxxrv-ed813687835a92784865e29ca937fa69 av_three_fifth  column-form white-bkg first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba\">\n#top .av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba{\npadding-bottom:10px;\ncolor:#000e78;\n}\nbody .av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .special-heading-inner-border{\nborder-color:#000e78;\n}\n.av-special-heading.av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-m4auzxjq-528a2e5d99e650173b0fd30a4c0c4bba av-special-heading-h3 custom-color-heading blockquote modern-quote modern-centered'><h3 class='av-special-heading-tag '  >Book a Demo<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-m4av0qkv-a50042b97728bc28c371ad31790bf0af '  ><div class='avia_textblock green-btn' ><style>\n#top .column-form.white-bkg #mktoForm_3182.mktoForm {width:100% !important;}#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow {width:100%;display:block;}#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+1), #top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+2) { width: 49% !important; margin: 0 1% 0 0; width: 49% !important;}@media (max-width: 480px) {#top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+1), #top .column-form.white-bkg #mktoForm_3182.mktoForm .mktoFormRow .mktoFormRow .mktoFormCol:nth-of-type(n+2){width:100% !important;}}<\/style>\n<form id=\"mktoForm_3182\"><\/form>\n<p><script>\nMktoForms2.loadForm(\"\/\/go.jamasoftware.com\", \"078-EIF-407\", 3182);\nMktoForms2.whenReady(function (form){\nvar redirectTimeMs = 4000;  \n\/*Add an onSuccess handler*\/ \nform.onSuccess(function(values, followUpUrl){\nvar thankYouURL = followUpUrl+  \"?FirstName=\" + encodeURIComponent(values.FirstName) +  \"&LastName=\" + encodeURIComponent(values.LastName)+  \"&Email=\" + encodeURIComponent(values.Email);console.log(thankYouURL);\ndocument.location.href = thankYouURL;\nreturn false;\n});\n});\n<\/script><\/p>\n<\/div><\/section><\/div><\/div><!--close flex column wrapper. 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