{"id":10826,"date":"2022-10-13T13:32:47","date_gmt":"2022-10-13T11:32:47","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=10826"},"modified":"2022-10-13T13:32:47","modified_gmt":"2022-10-13T11:32:47","slug":"clinical-evaluation","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/10\/13\/clinical-evaluation\/","title":{"rendered":"Clinical Evaluation: Seamless documentation"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-71mvt1-0c9026b77829976ed67b1cd6a8feae71\">\n.avia-section.av-71mvt1-0c9026b77829976ed67b1cd6a8feae71{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/10\/shutterstock_381068455-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-71mvt1-0c9026b77829976ed67b1cd6a8feae71 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  av-mini-hide 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-10826'><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-10826'><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-l96ytund-f6917bfb5c8c70475e12500d9d1af4fa\">\n#top .av-special-heading.av-l96ytund-f6917bfb5c8c70475e12500d9d1af4fa{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l96ytund-f6917bfb5c8c70475e12500d9d1af4fa .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l96ytund-f6917bfb5c8c70475e12500d9d1af4fa .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l96ytund-f6917bfb5c8c70475e12500d9d1af4fa 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\"  >Clinical Evaluation: Seamless documentation according to MDR<\/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>The Clinical Evaluation is part of the technical documentation of medical devices and in vitro diagnostics &#8211; a part that you must carry out in order to market your medical devices safely and efficiently in Europe. This is because manufacturers must prepare a comprehensive Clinical Evaluation as part of the conformity assessment procedure in order to obtain marketing authorisation.<\/p>\n<p>To increase the safety of patients and users, this is therefore subject to particularly high requirements and regulations. What you should consider and how you can compile a Clinical Evaluation without gaps? We will show you.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_3'  class='avia-section av-v701c5-830df8df9784497b835b516744ad38ab 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-10826'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-27sb5x-4085c66747e69cd624c3c8f32df9c0e3\">\n.flex_column.av-27sb5x-4085c66747e69cd624c3c8f32df9c0e3{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-27sb5x-4085c66747e69cd624c3c8f32df9c0e3 av_three_fifth  avia-builder-el-6  el_before_av_two_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-l96yuwcw-d274585a8868d6ed42a14b8998320055\">\n#top .av-special-heading.av-l96yuwcw-d274585a8868d6ed42a14b8998320055{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l96yuwcw-d274585a8868d6ed42a14b8998320055 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l96yuwcw-d274585a8868d6ed42a14b8998320055 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l96yuwcw-d274585a8868d6ed42a14b8998320055 av-special-heading-h2 blockquote modern-quote  avia-builder-el-7  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What is the purpose of the Clinical Evaluation?<\/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>According to MDR (EU) 2017\/745, the Clinical Evaluation serves to demonstrate compliance with the essential safety and performance requirements. It also shows that undesirable side effects have been considered and excluded during manufacture. In general, the Clinical Evaluation is therefore evidence that the medical device has an acceptable risk-benefit balance.<\/p>\n<p>Since it must also be regularly supplemented and updated after the medical device has been placed on the market, patients and users benefit from a high level of safety if medical device manufacturers continuously and proactively update the assessment report throughout the entire life cycle.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-d1m91-5c56afd7b89a48dc7f70d4b8eefc7093\">\n.flex_column.av-d1m91-5c56afd7b89a48dc7f70d4b8eefc7093{\nborder-radius:8px 8px 8px 8px;\npadding:15px 15px 15px 15px;\nbackground-color:#92afab;\n}\n<\/style>\n<div  class='flex_column av-d1m91-5c56afd7b89a48dc7f70d4b8eefc7093 av_two_fifth  avia-builder-el-9  el_after_av_three_fifth  avia-builder-el-last  flex_column_div  '     ><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\" ><h3>Good to know: This applies according to MDR<\/h3>\n<p>Manufacturers themselves determine the scope of the document. However, this decision must be justified. According to the MDR, &#8220;the scope of the clinical evidence shall be proportionate to the characteristics of the device and its intended purpose&#8221;. (MDR, Article 61 (1)).<\/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-11  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-10826'><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-12  el_before_av_three_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-av_heading-39f75a38b9a2883ada1316ef91d7800c\">\n#top .av-special-heading.av-av_heading-39f75a38b9a2883ada1316ef91d7800c{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-39f75a38b9a2883ada1316ef91d7800c .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-39f75a38b9a2883ada1316ef91d7800c .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-39f75a38b9a2883ada1316ef91d7800c av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What does the Clinical Evaluation according to MDR include?<\/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>In addition to the systematic collection and evaluation of clinical data, the Clinical Evaluation also includes clinical follow-up after the medical device has been placed on the market (post-market surveillance).<\/p>\n<p>In principle, the preparation of the Clinical Evaluation follows a systematic, defined process. Article 61 of the MDR specifies the following principles for the clinical evaluation:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-l96sfdic-f21037e8b51ce15acbae0485af3cb664  avia-builder-el-15  el_after_av_textblock  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l96sfdic-f21037e8b51ce15acbae0485af3cb664 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-1pugu6i-9e60516735bf049216f11fd412a7e98a 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Literature\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Literature<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>use and evaluate relevant scientific literature &#8211; appropriate to the medical device &#8211; on safety, performance, design features and intended use.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1ciw6ei-cebe4e09b7766160c6b79cf4ebcad7ed 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Evaluation\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Evaluation<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>create a critical appraisal of the results of all available clinical trials.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-p1rd6y-bdb61c1b8afe090cc98ecc7fc42e5e25 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Other options\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Other options<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>and take into account any other treatment options that may also be currently available.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1oqgi2t-b8d3d47f423530feffcb075886bc64d2\">\n.flex_column.av-1oqgi2t-b8d3d47f423530feffcb075886bc64d2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1oqgi2t-b8d3d47f423530feffcb075886bc64d2 av_three_fifth  avia-builder-el-16  el_after_av_three_fourth  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_top av-l96sggur-59ef30cb3c1c1002871577dd49953fb9  avia-builder-el-17  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Strategic planning\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue864' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Strategic planning<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>See the KB not only as an obligation, but as an opportunity for your strategic planning. By integrating risk analysis and information from market research, among other things, right from the start, you create important synergies for later processes. For example, you avoid duplication of research or documentation efforts.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/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_5'  class='avia-section av-1ao7med-419e2de3f6c1d7111051c6d065eadbed alternate_color avia-section-default avia-no-border-styling  avia-builder-el-18  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-10826'><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_one_full  avia-builder-el-19  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-av_heading-7cfebe1036be86b96101188c9464e942\">\n#top .av-special-heading.av-av_heading-7cfebe1036be86b96101188c9464e942{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-7cfebe1036be86b96101188c9464e942 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-7cfebe1036be86b96101188c9464e942 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-7cfebe1036be86b96101188c9464e942 av-special-heading-h2 blockquote modern-quote  avia-builder-el-20  avia-builder-el-no-sibling '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >What do you have to consider as a manufacturer?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><div class='flex_column_table av-v5mqn9-5688da3e2464af93e57cb0ca5bbfab21 sc-av_two_fifth av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-v5mqn9-5688da3e2464af93e57cb0ca5bbfab21\">\n.flex_column.av-v5mqn9-5688da3e2464af93e57cb0ca5bbfab21{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-v5mqn9-5688da3e2464af93e57cb0ca5bbfab21 av_two_fifth  avia-builder-el-21  el_after_av_one_full  el_before_av_three_fifth  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6ujwp58-94d042b9bc1e623e50003bc4aee8cae6\">\n.avia-image-container.av-l6ujwp58-94d042b9bc1e623e50003bc4aee8cae6 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-l6ujwp58-94d042b9bc1e623e50003bc4aee8cae6 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-l6ujwp58-94d042b9bc1e623e50003bc4aee8cae6 av-styling- avia-align-center  avia-builder-el-22  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-9373 avia-img-lazy-loading-not-9373 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-scaled.jpg\" alt='Ein Mensch zeigt auf einen Bildschirm. In einer Hand h\u00e4lt er ein Stetoskop' title='shutterstock_519284317'  height=\"1707\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/div><div class='av-flex-placeholder'><\/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_three_fifth  avia-builder-el-23  el_after_av_two_fifth  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-e6df64fff3798d4c0c49b098358cea8f\">\n#top .hr.hr-invisible.av-l6uk3c4a-e6df64fff3798d4c0c49b098358cea8f{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-e6df64fff3798d4c0c49b098358cea8f hr-invisible  avia-builder-el-24  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>As already mentioned above, the following applies to the Clinical Evaluation as part of the technical documentation: After placing the product on the market, the work is not yet finally completed. As a manufacturer, you are obliged to constantly update new findings and results, because the Clinical Evaluation is part of the post-market clinical follow-up (PMCF).<\/p>\n<p>Software solutions are recommended so that you can seamlessly maintain your Clinical Evaluation documentation throughout the entire life cycle of your medical device. By digitising this process, you reduce workload and keep your assessments consistent and unambiguous, as your data and analyses are updated centrally in one place. In addition, you can use existing information, e.g. the Essential Safety and Performance Requirements, for your assessment report.<\/p>\n<\/div><\/section><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/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-26  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-10826'><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-27  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-l96z4hdv-0c0e5e719b696e1814ba0316d99db7c9\">\n#top .av-special-heading.av-l96z4hdv-0c0e5e719b696e1814ba0316d99db7c9{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l96z4hdv-0c0e5e719b696e1814ba0316d99db7c9 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l96z4hdv-0c0e5e719b696e1814ba0316d99db7c9 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l96z4hdv-0c0e5e719b696e1814ba0316d99db7c9 av-special-heading-h2 blockquote modern-quote  avia-builder-el-28  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Our validated software 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>From risk management to regulatory and product requirements to usability and of course the KB. With the extension module of the BAYOOSOFT Risk Manager, we enable you to generate the KB in compliance with the MDR and MEDDEV 2.7.1 rev4. Learn <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#clinical-evaluation\" target=\"_blank\" rel=\"noopener\">more<\/a>.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-86d340ec50d039963bf30bd2c544bf62\">\n#top .hr.hr-invisible.av-l6uk3c4a-86d340ec50d039963bf30bd2c544bf62{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-86d340ec50d039963bf30bd2c544bf62 hr-invisible  avia-builder-el-30  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<\/p>\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-31  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-10826'><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-32  el_before_av_three_fourth  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-l96sscxt-48acfe09eb097d9fc520cf5cb726673f\">\n.iconbox.av-l96sscxt-48acfe09eb097d9fc520cf5cb726673f .iconbox_content_container{\ncolor:#ffffff;\n}\n<\/style>\n<article  class='iconbox iconbox_top av-l96sscxt-48acfe09eb097d9fc520cf5cb726673f  avia-builder-el-33  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Get to know us\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Get to know us<\/h3><\/header><div class='iconbox_content_container av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: left\">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 style=\"text-align: left\">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><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\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-34  el_after_av_three_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6uk3c4a-aab2119f0956667a37c9c6d949f6c4e5\">\n#top .hr.hr-invisible.av-l6uk3c4a-aab2119f0956667a37c9c6d949f6c4e5{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l6uk3c4a-aab2119f0956667a37c9c6d949f6c4e5 hr-invisible  avia-builder-el-35  el_before_av_social_share  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='av-social-sharing-box av-zkyc4l-69e257dc1b605de8b7891beb7543c674 av-social-sharing-box-minimal  avia-builder-el-36  el_after_av_hr  avia-builder-el-last  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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