{"id":5196,"date":"2020-11-13T08:30:16","date_gmt":"2020-11-13T07:30:16","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=5196"},"modified":"2020-11-13T08:30:16","modified_gmt":"2020-11-13T07:30:16","slug":"landingpage-medica-2020","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/landingpage-medica-2020\/","title":{"rendered":"Landingpage Medica 2020"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6hsteg-f6dbcaa5add4e64eb10a41a1564aa1c2\">\n.avia-section.av-6hsteg-f6dbcaa5add4e64eb10a41a1564aa1c2{\nbackground-color:#ffffff;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/11\/RM_Zeichnung_voll.png);\nbackground-repeat:no-repeat;\nbackground-position:50% 0%;\nbackground-attachment:fixed;\n}\n.avia-section.av-6hsteg-f6dbcaa5add4e64eb10a41a1564aa1c2 .av-section-color-overlay{\nopacity:0.6;\nbackground-color:#ffffff;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-6hsteg-f6dbcaa5add4e64eb10a41a1564aa1c2 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_one_full  avia-builder-el-first  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-5196'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-khetkjly-45cc9ef99665cff0b838527f9aee87a0\">\n#top .av-special-heading.av-khetkjly-45cc9ef99665cff0b838527f9aee87a0{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-khetkjly-45cc9ef99665cff0b838527f9aee87a0 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-khetkjly-45cc9ef99665cff0b838527f9aee87a0 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-khetkjly-45cc9ef99665cff0b838527f9aee87a0 av-special-heading-h1 blockquote modern-quote  avia-builder-el-1  el_before_av_hr  avia-builder-el-first '><div class='av-subheading av-subheading_above'><p>Focus your energy on content instead of form<\/p>\n<\/div><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Technical Documentation with the BAYOOSOFT Risk Manager<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-khdtcamo-afab03575c02eddc63f682251a3ab810\">\n#top .hr.hr-invisible.av-khdtcamo-afab03575c02eddc63f682251a3ab810{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-khdtcamo-afab03575c02eddc63f682251a3ab810 hr-invisible  avia-builder-el-2  el_after_av_heading  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div  class='avia-button-wrap av-khdszw3l-7f11ccf40713ba72cb73c14335a0c04b-wrap avia-button-center  avia-builder-el-3  el_after_av_hr  avia-builder-el-last '><a href='#presentation-medica-2020'  class='avia-button av-khdszw3l-7f11ccf40713ba72cb73c14335a0c04b av-link-btn avia-icon_select-no avia-size-medium avia-position-center avia-color-theme-color'   aria-label=\"Lectures during the Medica and Webinars\"><span class='avia_iconbox_title' >Lectures during the Medica and Webinars<\/span><\/a><\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap 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-5196'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-etz56g-4a69a31a63cd66f7e2f61e51a0ab1656\">\n.flex_column.av-etz56g-4a69a31a63cd66f7e2f61e51a0ab1656{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-etz56g-4a69a31a63cd66f7e2f61e51a0ab1656 av_one_full  avia-builder-el-4  el_after_av_section  el_before_av_layout_row  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kh36jlui-f442c858840cff4a748b4b860730d3c3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As the world&#8217;s leading software solution, the <strong>BAYOOSOFT Risk Manager<\/strong> enables you to create technical documentation for medical devices and in-vitro diagnostics easily and efficiently.<\/p>\n<p>All information is captured in a clearly structured environment and the files are stored in an audit-proof manner and dynamically linked with each other in a fine-grained manner &#8211; making subsequent falsification or possible data loss a thing of the past. In addition, you avoid redundant data storage and can generate reports with the most current data at any time simply by pressing a button.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-khetqqd5-68df1c3148afe8893eab8ff6c9d65b05\">\n#top .av-special-heading.av-khetqqd5-68df1c3148afe8893eab8ff6c9d65b05{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-khetqqd5-68df1c3148afe8893eab8ff6c9d65b05 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-khetqqd5-68df1c3148afe8893eab8ff6c9d65b05 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-khetqqd5-68df1c3148afe8893eab8ff6c9d65b05 av-special-heading-h3 blockquote modern-quote  avia-builder-el-6  el_after_av_textblock  avia-builder-el-last '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Your development and approval process is accelerated with BAYOOSOFT Risk Manager: Concentrate on the 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av-khdudhj7-32ec9f68fc25c84abf4d0ab5cc704260 av-gridrow-cell av_two_third no_margin  avia-builder-el-15  el_before_av_cell_one_third  avia-builder-el-first '  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-khablcni-191d8ab0b05bf0a53cccf1c3f588d785\">\n.avia-image-container.av-khablcni-191d8ab0b05bf0a53cccf1c3f588d785 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-khablcni-191d8ab0b05bf0a53cccf1c3f588d785 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-khablcni-191d8ab0b05bf0a53cccf1c3f588d785 av-styling- avia-align-center  avia-builder-el-16  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-5031 avia-img-lazy-loading-not-5031 avia_image ' 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sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/div><\/div><\/div>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-khdudc53-3255bf16f8251fab2dcbb87404edbded\">\n.flex_cell.av-khdudc53-3255bf16f8251fab2dcbb87404edbded{\nvertical-align:middle;\n}\n.responsive #top #wrap_all .flex_cell.av-khdudc53-3255bf16f8251fab2dcbb87404edbded{\npadding:30px 30px 30px 30px !important;\n}\n<\/style>\n<div class='flex_cell av-khdudc53-3255bf16f8251fab2dcbb87404edbded av-gridrow-cell av_one_third no_margin  avia-builder-el-17  el_after_av_cell_two_third  avia-builder-el-last '  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kheu3fit-47fa16c84a77539bf9eb475d5e73e18f\">\n#top .av-special-heading.av-kheu3fit-47fa16c84a77539bf9eb475d5e73e18f{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu3fit-47fa16c84a77539bf9eb475d5e73e18f .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu3fit-47fa16c84a77539bf9eb475d5e73e18f .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu3fit-47fa16c84a77539bf9eb475d5e73e18f av-special-heading-h2 blockquote modern-quote  avia-builder-el-18  avia-builder-el-no-sibling '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >The Risk Manager modules at a glance<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/p>\n<div id='presentation-medica-2020'  class='avia-section av-khdudq0n-3b0c1252d513b2c53ec140a0a3877160 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-19  el_after_av_layout_row  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-5196'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kheu3qjv-aa1a3f13dd934417c3ea84c98351d8c8\">\n#top .av-special-heading.av-kheu3qjv-aa1a3f13dd934417c3ea84c98351d8c8{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu3qjv-aa1a3f13dd934417c3ea84c98351d8c8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu3qjv-aa1a3f13dd934417c3ea84c98351d8c8 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu3qjv-aa1a3f13dd934417c3ea84c98351d8c8 av-special-heading-h3 blockquote modern-quote  avia-builder-el-20  el_before_av_one_half  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Inform yourself in our lectures at Medica 2020<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb\">\n.flex_column.av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb av_one_half  avia-builder-el-21  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kheu3w5w-6350630661e629cabf43e589f05f00d7\">\n#top .av-special-heading.av-kheu3w5w-6350630661e629cabf43e589f05f00d7{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu3w5w-6350630661e629cabf43e589f05f00d7 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu3w5w-6350630661e629cabf43e589f05f00d7 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu3w5w-6350630661e629cabf43e589f05f00d7 av-special-heading-h5  avia-builder-el-22  el_before_av_toggle_container  avia-builder-el-first '><h5 class='av-special-heading-tag '  itemprop=\"headline\"  >Monday, 16.11.2020<\/h5><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div  class='togglecontainer av-khdp6uhu-b84d7d7b36329bea0cfe87dde140509b  avia-builder-el-23  el_after_av_heading  avia-builder-el-last  toggle_close_all' >\n<section class='av_toggle_section av-rfpt64-18e47cda62fc678d0ee0c402a4348e7a'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-aria_expanded=\"Click to collapse: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\">10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world&#8217;s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.<\/p>\n<p>Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don&#8217;t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.<\/p>\n<div  class='avia-button-wrap av-1gbyolo-9eca4c8e020669fa13aa5661711c8d31-wrap avia-button-center  avia-builder-el-24  el_before_av_button  avia-builder-el-first '><a href='https:\/\/bit.ly\/2THrSvf'  class='avia-button av-1gbyolo-9eca4c8e020669fa13aa5661711c8d31 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-qb5jq4-f9056d597124b8ffd25e836d90a21548'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-aria_expanded=\"Click to collapse: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\">11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.<\/p>\n<div  class='avia-button-wrap av-1cxztm4-b683b4b3ede9a6bdc1e1374c020bd729-wrap avia-button-center  avia-builder-el-25  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3mGKt6Y'  class='avia-button av-1cxztm4-b683b4b3ede9a6bdc1e1374c020bd729 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-o3415o-d6ed4be9d44f6fb8ffe54f842d078f66'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-aria_expanded=\"Click to collapse: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\">2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.<\/p>\n<p>But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child&#8217;s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.<\/p>\n<div  class='avia-button-wrap av-18vurgs-e2de5efc37496549b26f32d119d64572-wrap avia-button-center  avia-builder-el-26  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3oQ33vq'  class='avia-button av-18vurgs-e2de5efc37496549b26f32d119d64572 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-mlag2k-c3769ae9bd87d5937d25f4a0f3755b90'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"3:30 P.M.: Risks in the Software Life Cycle IEC 62304 - tool-supported traceability\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 3:30 P.M.: Risks in the Software Life Cycle IEC 62304 - tool-supported traceability\" data-aria_expanded=\"Click to collapse: 3:30 P.M.: Risks in the Software Life Cycle IEC 62304 - tool-supported traceability\">3:30 P.M.: Risks in the Software Life Cycle IEC 62304 - tool-supported traceability<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>IEC 62304 defines a framework for MP software life cycles. Mostly traceability matrices are used to prove a compliant development &#8211; especially for large systems it becomes challenging. We will show you how the use of digital tools can support this process as well as a seamless integration into risk management and thus accelerate the approval process.<\/p>\n<div  class='avia-button-wrap av-16gb6oc-251d80864b2791b38cfa0fcf9c4ed1f0-wrap avia-button-center  avia-builder-el-27  el_after_av_button  avia-builder-el-last '><a href='https:\/\/bit.ly\/3mDlBwS'  class='avia-button av-16gb6oc-251d80864b2791b38cfa0fcf9c4ed1f0 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2afkk8-33b192c4b913f21503f00800e6864d09\">\n.flex_column.av-2afkk8-33b192c4b913f21503f00800e6864d09{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2afkk8-33b192c4b913f21503f00800e6864d09 av_one_half  avia-builder-el-28  el_after_av_one_half  el_before_av_one_half  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kheu40ys-51d5e9297151ee47b3514fccd8d395d2\">\n#top .av-special-heading.av-kheu40ys-51d5e9297151ee47b3514fccd8d395d2{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu40ys-51d5e9297151ee47b3514fccd8d395d2 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu40ys-51d5e9297151ee47b3514fccd8d395d2 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu40ys-51d5e9297151ee47b3514fccd8d395d2 av-special-heading-h5  avia-builder-el-29  el_before_av_toggle_container  avia-builder-el-first '><h5 class='av-special-heading-tag '  itemprop=\"headline\"  >Tuesday, 17.11.2020<\/h5><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div  class='togglecontainer av-khdp6uhu-b84d7d7b36329bea0cfe87dde140509b  avia-builder-el-30  el_after_av_heading  avia-builder-el-last  toggle_close_all' >\n<section class='av_toggle_section av-k3bmuk-63eb4292fa36a7bf38d39fbd974e0b28'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-5' data-fake-id='#toggle-id-5' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5' data-slide-speed=\"200\" data-title=\"10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-aria_expanded=\"Click to collapse: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\">10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' aria-labelledby='toggle-toggle-id-5' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world&#8217;s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.<\/p>\n<p>Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don&#8217;t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.<\/p>\n<div  class='avia-button-wrap av-13dg9u4-a6454fe13507559e38fd17ea88338de4-wrap avia-button-center  avia-builder-el-31  el_before_av_button  avia-builder-el-first '><a href='https:\/\/bit.ly\/2THrSvf'  class='avia-button av-13dg9u4-a6454fe13507559e38fd17ea88338de4 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-isryrw-9f6fc2df067f7b4d0aa2c5a8f70ed9bd'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-6' data-fake-id='#toggle-id-6' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-6' data-slide-speed=\"200\" data-title=\"11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-aria_expanded=\"Click to collapse: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\">11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-6' aria-labelledby='toggle-toggle-id-6' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.<\/p>\n<div  class='avia-button-wrap av-10anxl8-746584c4db83b98650dcbc1f63fa9934-wrap avia-button-center  avia-builder-el-32  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3mGKt6Y'  class='avia-button av-10anxl8-746584c4db83b98650dcbc1f63fa9934 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-hamt0s-dd612a6b3177f16f482cd9c1c055068c'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-7' data-fake-id='#toggle-id-7' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-7' data-slide-speed=\"200\" data-title=\"2:00 P.M.: Stop the Sisyphus work - Very easy adaptation and versioning of the technical documentation\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 2:00 P.M.: Stop the Sisyphus work - Very easy adaptation and versioning of the technical documentation\" data-aria_expanded=\"Click to collapse: 2:00 P.M.: Stop the Sisyphus work - Very easy adaptation and versioning of the technical documentation\">2:00 P.M.: Stop the Sisyphus work - Very easy adaptation and versioning of the technical documentation<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-7' aria-labelledby='toggle-toggle-id-7' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.<\/p>\n<p>But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child&#8217;s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.<\/p>\n<div  class='avia-button-wrap av-wrk3ng-0648fd71615924f6e0dd45d31d9891ad-wrap avia-button-center  avia-builder-el-33  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3oQ33vq'  class='avia-button av-wrk3ng-0648fd71615924f6e0dd45d31d9891ad av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-5f5m4-8df57ad47bde8f09535e2705c449743b'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-8' data-fake-id='#toggle-id-8' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-8' data-slide-speed=\"200\" data-title=\"3:30 P.M.: Accelerate the clinical evaluation process with tool support\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 3:30 P.M.: Accelerate the clinical evaluation process with tool support\" data-aria_expanded=\"Click to collapse: 3:30 P.M.: Accelerate the clinical evaluation process with tool support\">3:30 P.M.: Accelerate the clinical evaluation process with tool support<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-8' aria-labelledby='toggle-toggle-id-8' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The use of digital tools can help medical device manufacturers to map the process of clinical evaluation according to the Medical Device Directive MDR 2017\/745 at a central location, to standardize the procedure and to document it in a comprehensible way at any time, thus making this part of quality management faster and more efficient.<\/p>\n<div  class='avia-button-wrap av-saehmk-d94071ef59576c1b87280e3d839f0cb6-wrap avia-button-center  avia-builder-el-34  el_after_av_button  avia-builder-el-last '><a href='https:\/\/bit.ly\/3oOmDYV'  class='avia-button av-saehmk-d94071ef59576c1b87280e3d839f0cb6 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb\">\n.flex_column.av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2afkk8-9da0c3b5d63d97a7400bc834e87b24fb av_one_half  avia-builder-el-35  el_after_av_one_half  el_before_av_one_half  first 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-kheu46lh-7acccbcf328d8cc259daa9b020bf393b\">\n#top .av-special-heading.av-kheu46lh-7acccbcf328d8cc259daa9b020bf393b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu46lh-7acccbcf328d8cc259daa9b020bf393b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu46lh-7acccbcf328d8cc259daa9b020bf393b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu46lh-7acccbcf328d8cc259daa9b020bf393b av-special-heading-h5  avia-builder-el-36  el_before_av_toggle_container  avia-builder-el-first '><h5 class='av-special-heading-tag '  itemprop=\"headline\"  >Wednesday, 18.11.2020<\/h5><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div  class='togglecontainer av-khdp6uhu-b84d7d7b36329bea0cfe87dde140509b  avia-builder-el-37  el_after_av_heading  avia-builder-el-last  toggle_close_all' >\n<section class='av_toggle_section av-ea7cbw-724fe90b52566b5292baf0d02cafff91'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-9' data-fake-id='#toggle-id-9' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-9' data-slide-speed=\"200\" data-title=\"10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-aria_expanded=\"Click to collapse: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\">10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-9' aria-labelledby='toggle-toggle-id-9' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world&#8217;s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.<\/p>\n<p>Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don&#8217;t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.<\/p>\n<div  class='avia-button-wrap av-p3gz0c-743a2e09c6a83f0c0399a9d8f01add23-wrap avia-button-center  avia-builder-el-38  el_before_av_button  avia-builder-el-first '><a href='https:\/\/bit.ly\/2THrSvf'  class='avia-button av-p3gz0c-743a2e09c6a83f0c0399a9d8f01add23 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-4959o-c4cabcbf3c480570a37be1ee636ed151'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-10' data-fake-id='#toggle-id-10' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-10' data-slide-speed=\"200\" data-title=\"11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-aria_expanded=\"Click to collapse: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\">11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-10' aria-labelledby='toggle-toggle-id-10' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.<\/p>\n<div  class='avia-button-wrap av-mrbs30-ac8a047eb2ca0c41788445e0c81e8231-wrap avia-button-center  avia-builder-el-39  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3mGKt6Y'  class='avia-button av-mrbs30-ac8a047eb2ca0c41788445e0c81e8231 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-balo64-c0ef19ca0452c848197501b606b48817'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-11' data-fake-id='#toggle-id-11' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-11' data-slide-speed=\"200\" data-title=\"2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-aria_expanded=\"Click to collapse: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\">2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-11' aria-labelledby='toggle-toggle-id-11' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.<\/p>\n<p>But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child&#8217;s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.<\/p>\n<div  class='avia-button-wrap av-js2jgc-1736780ccdcb0e9ead896bca77281b45-wrap avia-button-center  avia-builder-el-40  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3oQ33vq'  class='avia-button av-js2jgc-1736780ccdcb0e9ead896bca77281b45 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-9n7gv0-c4b8156a0f3d2356898871963850fdbf'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-12' data-fake-id='#toggle-id-12' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-12' data-slide-speed=\"200\" data-title=\"3:30 P.M.: Risks in the software life cycle IEC 62304 - tool-supported traceability\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 3:30 P.M.: Risks in the software life cycle IEC 62304 - tool-supported traceability\" data-aria_expanded=\"Click to collapse: 3:30 P.M.: Risks in the software life cycle IEC 62304 - tool-supported traceability\">3:30 P.M.: Risks in the software life cycle IEC 62304 - tool-supported traceability<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-12' aria-labelledby='toggle-toggle-id-12' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>IEC 62304 defines a framework for MP software life cycles. Mostly traceability matrices are used to prove a compliant development &#8211; especially for large systems it becomes challenging. We will show you how the use of digital tools can support this process as well as a seamless integration into risk management and thus accelerate the approval process.<\/p>\n<div  class='avia-button-wrap av-f9fruk-c8768e9d828e465d6006e893993b8c60-wrap avia-button-center  avia-builder-el-41  el_after_av_button  avia-builder-el-last '><a href='https:\/\/bit.ly\/3mDlBwS'  class='avia-button av-f9fruk-c8768e9d828e465d6006e893993b8c60 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2afkk8-33b192c4b913f21503f00800e6864d09\">\n.flex_column.av-2afkk8-33b192c4b913f21503f00800e6864d09{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2afkk8-33b192c4b913f21503f00800e6864d09 av_one_half  avia-builder-el-42  el_after_av_one_half  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-kheu4cyt-3a1908a3ab2e6e739204fda5cb7df065\">\n#top .av-special-heading.av-kheu4cyt-3a1908a3ab2e6e739204fda5cb7df065{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kheu4cyt-3a1908a3ab2e6e739204fda5cb7df065 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kheu4cyt-3a1908a3ab2e6e739204fda5cb7df065 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kheu4cyt-3a1908a3ab2e6e739204fda5cb7df065 av-special-heading-h5  avia-builder-el-43  el_before_av_toggle_container  avia-builder-el-first '><h5 class='av-special-heading-tag '  itemprop=\"headline\"  >Thursday, 19.11.2020<\/h5><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div  class='togglecontainer av-khdp6uhu-b84d7d7b36329bea0cfe87dde140509b  avia-builder-el-44  el_after_av_heading  avia-builder-el-last  toggle_close_all' >\n<section class='av_toggle_section av-7y4lws-beedd63d2d18f140135aff3360ed4daa'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-13' data-fake-id='#toggle-id-13' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-13' data-slide-speed=\"200\" data-title=\"10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\" data-aria_expanded=\"Click to collapse: 10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager\">10:00 A.M.: Focus on content instead of form - technical documentation with the Risk Manager<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-13' aria-labelledby='toggle-toggle-id-13' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The regulatory requirements for the development and marketing of medical devices have increased continuously in recent years. The EU Medical Devices Regulation has given rise to numerous discussions. For the manufacturers of medical devices this means a continuously increasing documentation effort. As the world&#8217;s leading software solution, the BAYOOSOFT Risk Manager supports you in creating technical documentation for medical devices and in-vitro diagnostics.<\/p>\n<p>Do you also want to speed up your way to approval? Get to know the Risk Manager better in our presentation. Don&#8217;t miss the opportunity to familiarize yourself risk-free and first-hand with the latest version of the validated approval accelerator.<\/p>\n<div  class='avia-button-wrap av-bvs9t8-aa1308db6eeca4760fb9793213af2c84-wrap avia-button-center  avia-builder-el-45  el_before_av_button  avia-builder-el-first '><a href='https:\/\/bit.ly\/2THrSvf'  class='avia-button av-bvs9t8-aa1308db6eeca4760fb9793213af2c84 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-5irobg-e7839e15c84b4f9c316ec15a4367e36f'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-14' data-fake-id='#toggle-id-14' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-14' data-slide-speed=\"200\" data-title=\"11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\" data-aria_expanded=\"Click to collapse: 11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill\">11:30 A.M.: Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-14' aria-labelledby='toggle-toggle-id-14' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data sets, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process in the face of more than 400 pages of requirements and more than 1,500 tests for applicability. Using the BAYOOSOFT Risk Manager, we will show you how you can accelerate this process systematically and interactively by up to 62%.<\/p>\n<div  class='avia-button-wrap av-9vgqyk-b96a3e68796c103ae14d2b4dd3a24400-wrap avia-button-center  avia-builder-el-46  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3mGKt6Y'  class='avia-button av-9vgqyk-b96a3e68796c103ae14d2b4dd3a24400 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-4i235o-9ac8faafee978146fac73f4d2fc93fa7'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-15' data-fake-id='#toggle-id-15' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-15' data-slide-speed=\"200\" data-title=\"2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\" data-aria_expanded=\"Click to collapse: 2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation\">2:00 P.M.: Stop the Sisyphus work - very easy adaptation and versioning of the technical documentation<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-15' aria-labelledby='toggle-toggle-id-15' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The process for the initial creation of technical documentation for a medical device is still relatively clear and structured. From purpose and risk classification, across requirements and risk files, all aspects are considered piece by piece.<\/p>\n<p>But how do you proceed if the Technical Documentation needs to be revised due to market observation or other triggers? At which points do the changes have to be implemented and how do you later recognize the differences in different versions? We will show you how such changes to the technical documentation become child&#8217;s play thanks to the project- and version-based approach and the fine-grained dynamic data linking of the BAYOOSOFT Risk Manager.<\/p>\n<div  class='avia-button-wrap av-5tirfw-7adf2804332b031ca18b8d27dcb5581b-wrap avia-button-center  avia-builder-el-47  el_after_av_button  el_before_av_button '><a href='https:\/\/bit.ly\/3oQ33vq'  class='avia-button av-5tirfw-7adf2804332b031ca18b8d27dcb5581b av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-22d5gs-1df654beec7d92042fd9643cd01ac4dc'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-16' data-fake-id='#toggle-id-16' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-16' data-slide-speed=\"200\" data-title=\"3:30 P.M.: Accelerate the clinical evaluation process with tool support\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: 3:30 P.M.: Accelerate the clinical evaluation process with tool support\" data-aria_expanded=\"Click to collapse: 3:30 P.M.: Accelerate the clinical evaluation process with tool support\">3:30 P.M.: Accelerate the clinical evaluation process with tool support<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-16' aria-labelledby='toggle-toggle-id-16' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The use of digital tools can help medical device manufacturers to map the process of clinical evaluation according to the Medical Device Directive MDR 2017\/745 at a central location, to standardize the procedure and to document it in a comprehensible way at any time, thus making this part of quality management faster and more efficient.<\/p>\n<div  class='avia-button-wrap av-2lr8ks-6e4e41465b44b0c93314539a09060060-wrap avia-button-center  avia-builder-el-48  el_after_av_button  avia-builder-el-last '><a href='https:\/\/bit.ly\/3oOmDYV'  class='avia-button av-2lr8ks-6e4e41465b44b0c93314539a09060060 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Open access link now\"><span class='avia_iconbox_title' >Open access link now<\/span><\/a><\/div>\n<\/div><\/div><\/div><\/section>\n<\/div><\/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-khdufqi7-f4bc1e5706d4fa02a23b171c2ac2ac3c\">\n.avia-section.av-khdufqi7-f4bc1e5706d4fa02a23b171c2ac2ac3c{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/11\/RM_Zeichnung_voll.png);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-khdufqi7-f4bc1e5706d4fa02a23b171c2ac2ac3c main_color avia-section-default avia-no-border-styling  avia-builder-el-49  el_after_av_section  avia-builder-el-last  avia-full-stretch avia-bg-style-scroll container_wrap fullsize'  data-section-bg-repeat='stretch'><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-5196'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-77ptd4-e83304d137bba3c95e547bab9e0ff274\">\n.flex_column.av-77ptd4-e83304d137bba3c95e547bab9e0ff274{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-77ptd4-e83304d137bba3c95e547bab9e0ff274 av_one_third  avia-builder-el-50  el_before_av_one_third  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-js4ko-1b9e2fd779988990441466413ba30b87\">\n.flex_column.av-js4ko-1b9e2fd779988990441466413ba30b87{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-js4ko-1b9e2fd779988990441466413ba30b87 av_one_third  avia-builder-el-51  el_after_av_one_third  el_before_av_one_third  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kh4p17uv-854c9df68d39ea83bf92e954a61c217d '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h3>You cannot be present at Medica? Then visit one of our webinars:<\/h3>\n<\/div><\/section><br \/>\n<div  class='avia-builder-widget-area clearfix  avia-builder-el-53  el_after_av_textblock  avia-builder-el-last '><div id=\"em_widget-9\" class=\"widget clearfix widget_em_widget\"><h3 class=\"widgettitle\">Anstehende Online-Produktpr\u00e4sentationen<\/h3><div class=\"em pixelbones em-list-widget em-events-widget\"><ul><li>Keine Veranstaltungen<\/li><\/ul><\/div><\/div><div id=\"em_widget-10\" class=\"widget clearfix widget_em_widget\"><h3 class=\"widgettitle\">Upcoming online product presentations<\/h3><div class=\"em pixelbones em-list-widget em-events-widget\"><ul><li>Keine Veranstaltungen<\/li><\/ul><\/div><\/div><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2fawag-5ee5dca176cd70cc4e381d04fa9eee94\">\n.flex_column.av-2fawag-5ee5dca176cd70cc4e381d04fa9eee94{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2fawag-5ee5dca176cd70cc4e381d04fa9eee94 av_one_third  avia-builder-el-54  el_after_av_one_third  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div>\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":33,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5196","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/5196","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=5196"}],"version-history":[{"count":5,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/5196\/revisions"}],"predecessor-version":[{"id":5208,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/5196\/revisions\/5208"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=5196"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}