{"id":85771,"date":"2026-03-12T11:04:16","date_gmt":"2026-03-12T18:04:16","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=resource-page&#038;p=85771"},"modified":"2026-03-17T09:58:55","modified_gmt":"2026-03-17T16:58:55","slug":"iec-62304-edition-2-what-to-expect-and-why-it-matters-2","status":"publish","type":"resource-page","link":"https:\/\/www.jamasoftware.com\/webinar\/iec-62304-edition-2-what-to-expect-and-why-it-matters-2\/","title":{"rendered":"IEC 62304 Edition 2: What to Expect and Why It Matters"},"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-85771'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-2n29c2-c685524e4772cd5c998e331f0297fbf3 av_one_full  avia-builder-el-1  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div  '     ><\/div><div class='flex_column_table av-1izwc3p-7de049d07a9fe277148461c41fe269ff sc-av_two_fifth av-equal-height-column-flextable'><div  class='flex_column av-1izwc3p-7de049d07a9fe277148461c41fe269ff av_two_fifth  avia-builder-el-3  el_after_av_one_full  el_before_av_three_fifth  first flex_column_table_cell av-equal-height-column av-align-top  column-top-margin'     ><\/div><div class='av-flex-placeholder'><\/div><div  class='flex_column av-1dfyz5x-54808b3f45749ff6a22951230de9ef19 av_three_fifth  avia-builder-el-5  el_after_av_two_fifth  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-top  column-top-margin'     ><\/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-7  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-8  el_after_av_hr  avia-builder-el-last  first flex_column_div  '     ><section  class='av_textblock_section av-ljz0yqe6-4e9d14322421778c88a0b363f0043402 '  ><div class='avia_textblock' ><h3><b><span data-contrast=\"auto\">IEC 62304 Edition 2: What\u2019s Changing, What\u2019s Not, and How to Prepare<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">IEC 62304, the international standard governing medical device software lifecycle processes, is undergoing its first major revision in nearly 20 years. While the upcoming second edition aims to clarify requirements and better reflect modern software practices, it also intentionally preserves the stability manufacturers rely on for compliance.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This live webinar, co-presented with Medical Device HQ, provides a clear, practical view into the direction of IEC 62304 Edition 2, directly from someone involved in drafting the standard. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In this session, <\/span><b><span data-contrast=\"auto\">Christian Kaestner, member of IEC TC 62 \/ SC 62A and contributor to IEC 62304 Edition 2<\/span><\/b><span data-contrast=\"auto\">, joins <\/span><b><span data-contrast=\"auto\">Tom Rish,\u00a0 Head of GTM Strategy at Jama Software<\/span><\/b><span data-contrast=\"auto\"> to explain what is changing, what is deliberately not changing, and what these updates mean in practice for medical device and Software as a Medical Device (SaMD) manufacturers.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Key Takeaways:\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">Understand why IEC 62304 is being revised and the core objectives of Edition 2\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Learn how the IEC standardization process has shaped the scope and content of the revision\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Discover what the draft edition says about key topics like SaMD and artificial intelligence (AI).\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Hear why AI will not be a significant part of IEC 62304 \u2014 a deliberate design choice you need to understand.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"auto\">Find out which proposed changes are most likely to affect your organization and get practical advice on how to prepare.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Get a grounded, standards-focused perspective on IEC 62304 Edition 2 and what it means for your software lifecycle processes.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:279}\">\u00a0<\/span><\/p>\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-85771'><div class='entry-content-wrapper clearfix'>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" 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