{"id":10568,"date":"2022-08-10T16:56:53","date_gmt":"2022-08-10T14:56:53","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=10568"},"modified":"2022-08-17T16:57:08","modified_gmt":"2022-08-17T14:57:08","slug":"agile-iec-62304","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/08\/10\/agile-iec-62304\/","title":{"rendered":"Agile IEC 62304: How you can use the standard in the development process"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-71mvt1-399ccd32156fc588d7356cca3951e404\">\n.avia-section.av-71mvt1-399ccd32156fc588d7356cca3951e404{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/MedizintechnikNL-SOFT-scaled.jpg);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-71mvt1-399ccd32156fc588d7356cca3951e404 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='550'><div class='container av-section-cont-open' style='height:550px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='av_section_2'  class='avia-section av-ks945-d157b475cf82121b8e185c4fb0542a3f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-185f0n9-606ec91d692207294348e4563f50f4d4\">\n.flex_column.av-185f0n9-606ec91d692207294348e4563f50f4d4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-185f0n9-606ec91d692207294348e4563f50f4d4 av_three_fourth  avia-builder-el-2  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ulgvt7-3d89a0bbe54a4376ea62a2244a3ce162\">\n#top .av-special-heading.av-l6ulgvt7-3d89a0bbe54a4376ea62a2244a3ce162{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6ulgvt7-3d89a0bbe54a4376ea62a2244a3ce162 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6ulgvt7-3d89a0bbe54a4376ea62a2244a3ce162 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l6ulgvt7-3d89a0bbe54a4376ea62a2244a3ce162 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  el_before_av_textblock  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Agile IEC 62304: How you can use the standard in the development process<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Agile standards? The first thought is usually: What a contradiction. But with a look at IEC 62304, this can be quickly revised. The European standard for medical device software and software lifecycle processes explicitly mentions agility in the planning and development of the process.<\/p>\n<p>What IEC 62304 requires in the development of medical software and where agile working is made possible &#8211; we present it to you. You will also learn how you can use traceability matrices to conveniently prove conformity to the standard during development.<\/p>\n<\/div><\/section><\/p><\/div>\n\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-1ao7med-419e2de3f6c1d7111051c6d065eadbed\">\n.avia-section.av-1ao7med-419e2de3f6c1d7111051c6d065eadbed{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-1ao7med-419e2de3f6c1d7111051c6d065eadbed alternate_color avia-section-default avia-no-border-styling  avia-builder-el-5  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-6  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>When it comes to medical devices and their software, the highest priority is to ensure the safety of patients and users. However, IEC 62304 also states in Annex B: There is no known method for guaranteeing 100% SAFETY for any type of software.<\/p>\n<p>There are, of course, prerequisites in development nonetheless. For example, it is required that the medical device software is developed and maintained within a risk management system according to ISO 14971.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-v701c5-5ea04d32c9f779b3779031e81c4055c8 main_color avia-section-default avia-no-border-styling  avia-builder-el-8  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fifth  avia-builder-el-9  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Overall, the requirements of the standard include promoting safety:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-l6uf9qum-21864372418670d0a2e0cf7151c2d58a  avia-builder-el-11  el_after_av_textblock  el_before_av_textblock '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l6uf9qum-21864372418670d0a2e0cf7151c2d58a avia-iconlist-animate'>\n<li><div class='iconlist_icon av-5mwr48-a75aa1e557ce9388c4153bfee9bdcb5c avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue855' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: a quality management system (QMS)\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >a quality management system (QMS)<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-3kufgo-ecaa5004d3992b6a7e3b98f165767323 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue856' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: software engineering\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >software engineering<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-kpni6g-a23a48a60e7cd4926b70d2c308b6134c avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8d3' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: and a risk management system according to ISO 14971\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >and a risk management system according to ISO 14971<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Furthermore, IEC 62304 requires that risk management be defined as an integral part of the QMS in order to create a safe and repeatable development process together with established software engineering methods. In addition, software requirements must be considered in the context of a risk analysis.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-d1m91-6db9fb110924af473f5f433d7451067e\">\n@keyframes av_boxShadowEffect_av-d1m91-6db9fb110924af473f5f433d7451067e-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-d1m91-6db9fb110924af473f5f433d7451067e{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:3px;\nborder-color:#4abaab;\nborder-style:solid;\nborder-radius:8px 8px 8px 8px;\npadding:15px 15px 15px 15px;\nbackground-color:#92afab;\n}\n<\/style>\n<div  class='flex_column av-d1m91-6db9fb110924af473f5f433d7451067e av_two_fifth  avia-builder-el-13  el_after_av_three_fifth  avia-builder-el-last  flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-pvrltx-76c24258ca6066b015b824ac1776ce4f\">\n#top .av_textblock_section.av-pvrltx-76c24258ca6066b015b824ac1776ce4f .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-pvrltx-76c24258ca6066b015b824ac1776ce4f '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><strong>Good to know<\/strong><\/p>\n<p>If manufacturers use a purchased component or segment of unknown origin in the system architecture during the development of the medical device, this must be integrated into the risk management. The responsibility for this is automatically transferred to the manufacturer.<\/p>\n<\/div><\/section><\/div>\n\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-1ao7med-419e2de3f6c1d7111051c6d065eadbed\">\n.avia-section.av-1ao7med-419e2de3f6c1d7111051c6d065eadbed{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-1ao7med-419e2de3f6c1d7111051c6d065eadbed alternate_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-16  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ulnxzz-66187b5bb9072267f962baee29d49aad\">\n#top .av-special-heading.av-l6ulnxzz-66187b5bb9072267f962baee29d49aad{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6ulnxzz-66187b5bb9072267f962baee29d49aad .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6ulnxzz-66187b5bb9072267f962baee29d49aad .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l6ulnxzz-66187b5bb9072267f962baee29d49aad av-special-heading-h2 blockquote modern-quote  avia-builder-el-17  avia-builder-el-no-sibling '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >So where does IEC 62304 enable an agile planning and development process?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-v5mqn9-9cb4394b4ce04015537cb730e6d544db\">\n.flex_column.av-v5mqn9-9cb4394b4ce04015537cb730e6d544db{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-v5mqn9-9cb4394b4ce04015537cb730e6d544db av_two_fifth  avia-builder-el-18  el_after_av_three_fourth  el_before_av_two_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ujwp58-05245e540fb834fca5bb5df005e4ec66\">\n.avia-image-container.av-l6ujwp58-05245e540fb834fca5bb5df005e4ec66 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-l6ujwp58-05245e540fb834fca5bb5df005e4ec66 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-l6ujwp58-05245e540fb834fca5bb5df005e4ec66 av-styling- avia-align-center  avia-builder-el-19  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-10554 avia-img-lazy-loading-not-10554 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-scaled.jpg\" alt='Agile Softwareentwicklung - ein Mann sitzt vor 3 Bildschirmen' title='shutterstock_696061426'  height=\"1707\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/08\/shutterstock_696061426-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-f6999dfb593c66bc19a6e60372c20865\">\n.flex_column.av-27sb5x-f6999dfb593c66bc19a6e60372c20865{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-f6999dfb593c66bc19a6e60372c20865 av_two_fifth  avia-builder-el-20  el_after_av_two_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-0eb35c7f05a53cd38e759670f6c07e27\">\n#top .hr.hr-invisible.av-l6uk3c4a-0eb35c7f05a53cd38e759670f6c07e27{\nmargin-top:-20px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-0eb35c7f05a53cd38e759670f6c07e27 hr-invisible  avia-builder-el-21  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Already at the beginning of the software development process, the standard supports agility, because &#8220;planning is an iterative ACTIVITY that should be repeatedly reviewed and updated as development progresses&#8221; (IEC 62304, Annex B, B.5.1). If actions are always reflected and planning is adapted accordingly, planned control of the development process takes place.<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The planning must include the following points:<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_6'  class='avia-section av-v701c5-5ea04d32c9f779b3779031e81c4055c8 main_color avia-section-default avia-no-border-styling  avia-builder-el-24  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-25  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><div  class='avia-icon-list-container av-l6uijaqb-826804cb38317a3970168ba720a65d1a  avia-builder-el-26  el_before_av_textblock  avia-builder-el-first '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l6uijaqb-826804cb38317a3970168ba720a65d1a avia-iconlist-animate'>\n<li><div class='iconlist_icon av-9wa0js-b77d7a82c7a4d8867781f4e6e30c0001 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: a list of the processes used for development\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >a list of the processes used for development<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-20m45yg-60251b31328466f59b3ebbbd08155d84 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: results, tasks and activities to be delivered (incl. documentation of these)\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >results, tasks and activities to be delivered (incl. documentation of these)<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1oa9ih4-d66b885fe944a39d6ab22c45ffcb6a4f avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: a traceability of all requirements and measures for control and audit\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >a traceability of all requirements and measures for control and audit<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-15sp1bc-becb9c9f43242b3bdf66e3d17d1d14eb avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: a system for software configurations and changes\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >a system for software configurations and changes<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-mfzl7s-2d142c86c8aaabf7953dc3b3fc80c399 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: problem-solving measures at every stage of the product life cycle\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >problem-solving measures at every stage of the product life cycle<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Agile working can also be used for the product life cycle, because IEC 62304 does not require a concrete model for development. However, when software is developed in compliance with the standard, various dependencies between the individual processes become visible.<\/p>\n<p>For example, the classification of the system into a safety class should be completed after potential risks have been identified by means of risk analysis.<\/p>\n<\/div><\/section><\/p><\/div>\n\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-1ao7med-419e2de3f6c1d7111051c6d065eadbed\">\n.avia-section.av-1ao7med-419e2de3f6c1d7111051c6d065eadbed{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_7'  class='avia-section av-1ao7med-419e2de3f6c1d7111051c6d065eadbed alternate_color avia-section-default avia-no-border-styling  avia-builder-el-28  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-29  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ult8w4-525aac4a302b3f604579ed97513fcf00\">\n#top .av-special-heading.av-l6ult8w4-525aac4a302b3f604579ed97513fcf00{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6ult8w4-525aac4a302b3f604579ed97513fcf00 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6ult8w4-525aac4a302b3f604579ed97513fcf00 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l6ult8w4-525aac4a302b3f604579ed97513fcf00 av-special-heading-h2 blockquote modern-quote  avia-builder-el-30  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What is the role of verification and traceability according to IEC 62304?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>All requirements for the medical device software must be defined and verified by the manufacturer. This makes it comprehensible when the software is ready for use. If requirements are placed on the software in the risk management process, these must be evident in such a way that the risk control measures are also traceable.<\/p>\n<p>Traceability &#8211; IEC 62304 requires traceability for software requirements, as well as for the architecture, design and various components of the software, in addition to verification. All verifications must always be documented.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_8'  class='avia-section av-v701c5-5ea04d32c9f779b3779031e81c4055c8 main_color avia-section-default avia-no-border-styling  avia-builder-el-32  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-33  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ultxrw-a0be5c01869af93e2502fef261fce342\">\n#top .av-special-heading.av-l6ultxrw-a0be5c01869af93e2502fef261fce342{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6ultxrw-a0be5c01869af93e2502fef261fce342 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6ultxrw-a0be5c01869af93e2502fef261fce342 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l6ultxrw-a0be5c01869af93e2502fef261fce342 av-special-heading-h2 blockquote modern-quote  avia-builder-el-34  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Conformity to standards with traceability matrices<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Traceability matrices ensure that requirements are checked as part of appropriate validation processes. In addition, the matrices check whether the requirements have been implemented in the software and verified according to applicable requirements. Especially for systems, the manual creation of traceability matrices is a challenge when conformity to standards is required. Digital solutions offer a more convenient and consistently compliant option.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1ao7med-419e2de3f6c1d7111051c6d065eadbed\">\n.avia-section.av-1ao7med-419e2de3f6c1d7111051c6d065eadbed{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_9'  class='avia-section av-1ao7med-419e2de3f6c1d7111051c6d065eadbed alternate_color avia-section-default avia-no-border-styling  avia-builder-el-36  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-37  el_before_av_one_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uluhor-a8a8069744a23ff901bf491fc7e239d8\">\n#top .av-special-heading.av-l6uluhor-a8a8069744a23ff901bf491fc7e239d8{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6uluhor-a8a8069744a23ff901bf491fc7e239d8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6uluhor-a8a8069744a23ff901bf491fc7e239d8 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l6uluhor-a8a8069744a23ff901bf491fc7e239d8 av-special-heading-h2 blockquote modern-quote  avia-builder-el-38  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Our IEC 62304 compliant and safe solution for you<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-pvrltx-122d9e32ae3b19e2c6e53a589968b5e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The BAYOOSOFT Risk Manager offers a solution for the creation of technical documentation for the development of your medical device software. For this purpose, we combine the extension modules Requirements Engineering and REST API with the risk management according to ISO 14971. Learn more <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-eed4ce0b041928edd1f81a7fb7bb65c9\">\n#top .hr.hr-invisible.av-l6uk3c4a-eed4ce0b041928edd1f81a7fb7bb65c9{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-eed4ce0b041928edd1f81a7fb7bb65c9 hr-invisible  avia-builder-el-40  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-l6ui7cd9-451d7644abccd2a8231c85e3ebca7d81-wrap avia-button-center  avia-builder-el-41  el_after_av_hr  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#software-lifecycle-process-iec62304'  class='avia-button av-l6ui7cd9-451d7644abccd2a8231c85e3ebca7d81 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Find out more\"><span class='avia_iconbox_title' >Find out more<\/span><\/a><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-aewvqd-5e97d3fba1fd391c4da8168225233e75\">\n.flex_column.av-aewvqd-5e97d3fba1fd391c4da8168225233e75{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-aewvqd-5e97d3fba1fd391c4da8168225233e75 av_one_fifth  avia-builder-el-42  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_10'  class='avia-section av-v701c5-5ea04d32c9f779b3779031e81c4055c8 main_color avia-section-default avia-no-border-styling  avia-builder-el-43  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10568'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-d1m91-ebbe39796011f2599cc286cbade9d58b\">\n@keyframes av_boxShadowEffect_av-d1m91-ebbe39796011f2599cc286cbade9d58b-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-d1m91-ebbe39796011f2599cc286cbade9d58b{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:3px;\nborder-color:#4abaab;\nborder-style:solid;\nborder-radius:8px 8px 8px 8px;\npadding:15px 15px 15px 15px;\nbackground-color:#92afab;\n}\n<\/style>\n<div  class='flex_column av-d1m91-ebbe39796011f2599cc286cbade9d58b av_two_third  avia-builder-el-44  el_before_av_one_third  avia-builder-el-first  first flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-pvrltx-76c24258ca6066b015b824ac1776ce4f\">\n#top .av_textblock_section.av-pvrltx-76c24258ca6066b015b824ac1776ce4f .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-pvrltx-76c24258ca6066b015b824ac1776ce4f '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><strong>Get to know us<\/strong><\/p>\n<p>Would you like to test the BAYOOSOFT Risk Manager free of charge? Then use our free <a href=\"https:\/\/www.riskmanager.net\/en\/services\/test-now\/\" target=\"_blank\" rel=\"noopener\">TRIAL<\/a> for 30 days.<\/p>\n<p>Or visit an <a href=\"https:\/\/www.riskmanager.net\/en\/upcomming-events\/\" target=\"_blank\" rel=\"noopener\">online product presentation<\/a> and get to know the BAYOOSOFT Risk Manager directly on the system.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1oqgi2t-470df6957c48d0314c64f91bdd8c3498\">\n.flex_column.av-1oqgi2t-470df6957c48d0314c64f91bdd8c3498{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1oqgi2t-470df6957c48d0314c64f91bdd8c3498 av_one_third  avia-builder-el-46  el_after_av_two_third  el_before_av_hr  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-542f1bd82ba97a5f69367e7e3008f3f5\">\n#top .hr.hr-invisible.av-l6uk3c4a-542f1bd82ba97a5f69367e7e3008f3f5{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-542f1bd82ba97a5f69367e7e3008f3f5 hr-invisible  avia-builder-el-47  el_after_av_one_third  el_before_av_three_fourth '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-321811c73b8583a20d0b516b616e5c7e\">\n.flex_column.av-27sb5x-321811c73b8583a20d0b516b616e5c7e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-321811c73b8583a20d0b516b616e5c7e av_three_fourth  avia-builder-el-48  el_after_av_hr  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><div  class='av-social-sharing-box av-zkyc4l-69e257dc1b605de8b7891beb7543c674 av-social-sharing-box-minimal  avia-builder-el-49  avia-builder-el-no-sibling  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds interesting? 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