{"id":73968,"date":"2023-12-29T14:59:48","date_gmt":"2023-12-29T22:59:48","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=resource-page&#038;p=73968"},"modified":"2023-12-29T14:59:48","modified_gmt":"2023-12-29T22:59:48","slug":"understanding-integrated-risk-management-for-medical-devices","status":"publish","type":"resource-page","link":"https:\/\/www.jamasoftware.com\/whitepaper\/understanding-integrated-risk-management-for-medical-devices\/","title":{"rendered":"Understanding Integrated Risk Management for Medical Devices"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-1xk07xh-bbbec7a78c99a3bc73edbd2023502169 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  avia-builder-el-no-sibling  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-73968'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 sc-av_two_fifth av-equal-height-column-flextable'><div  class='flex_column av-1izwc3p-0dd97e9e1f6b6e68ec68b331b5ba7c20 av_two_fifth  avia-builder-el-1  el_before_av_three_fifth  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle  '     ><\/div><div class='av-flex-placeholder'><\/div><div  class='flex_column av-1dfyz5x-54808b3f45749ff6a22951230de9ef19 av_three_fifth  avia-builder-el-3  el_after_av_two_fifth  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-middle  '     ><p><br \/>\n<\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ljz2oc54-f4c32aef36da49fd259c264837168768\">\n#top .hr.hr-invisible.av-ljz2oc54-f4c32aef36da49fd259c264837168768{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-ljz2oc54-f4c32aef36da49fd259c264837168768 hr-invisible  avia-builder-el-6  el_after_av_three_fifth  el_before_av_one_full '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div  class='flex_column av-wga891-b5f28f812c6cab24bcc18bf3ef4b1f27 av_one_full  avia-builder-el-7  el_after_av_hr  avia-builder-el-last  first flex_column_div  '     ><section  class='av_textblock_section av-ljz0yqe6-e711d71884095728b0d3f8bbd256b9f5 '  ><div class='avia_textblock' ><p>A level of risk exists with all medical devices, no matter how simple they are. Companies developing medical devices are constantly considering who (or what environment, facility, etc.) could potentially be hurt by a device so they can help reduce risk and meet regulatory requirements. Risk management in the context of ISO 14971 is designed to support medical device manufacturers with these tasks \u2014 but not all approaches are created equal.<\/p>\n<p>The amount of time it takes to manage risks, connect specific risks to specific requirement tasks and pull together required documents to respond to an audit varies slightly depending on the approach. The risk management process is an integrated process that not only includes teams in product development, quality, but also many other parts of an organization.<\/p>\n<p><strong>In this whitepaper, we tap into the knowledge of industry and solution experts to uncover: <\/strong><\/p>\n<ul>\n<li><strong>Best practices for integrated risk management <\/strong><\/li>\n<li><strong>How to integrate risk-based thinking into product development cycles <\/strong><\/li>\n<li><strong>The importance of having end-to-end traceability to improve risk management <\/strong><\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/main><!-- close content main element --><\/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-73968'><div class='entry-content-wrapper clearfix'>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"73968\"\/>","protected":false},"excerpt":{"rendered":"","protected":false},"author":171,"featured_media":73971,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"resource_type":[887],"resource_industry":[901],"primary_topic":[915,918,919],"primary_challenge":[935,932],"competitors":[],"partners":[],"secondary_topic":[],"secondary_challenge":[],"class_list":["post-73968","resource-page","type-resource-page","status-publish","has-post-thumbnail","hentry","resource_type-whitepaper","resource_industry-medical-devices-life-science","primary_topic-requirements-management","primary_topic-risk-management","primary_topic-test-management","primary_challenge-change-impact-analysis","primary_challenge-regulatory-compliance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.0 (Yoast SEO v27.2) - 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