{"id":204,"date":"2024-04-25T11:32:00","date_gmt":"2024-04-25T16:32:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=204"},"modified":"2025-06-05T15:48:06","modified_gmt":"2025-06-05T20:48:06","slug":"behind-the-scenes-with-bsi-head-of-ivd-notified-body-alex-laan","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/behind-the-scenes-with-bsi-head-of-ivd-notified-body-alex-laan\/","title":{"rendered":"Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large is-resized\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQMLive_78__On_Demand_Knowledge_Center-1024x576.webp\" alt=\"behind the scenes with bsi head of ivd notified body, alex laan in conversation with rqm+'s margot borgel director , IVD global regulatory affairs RQM+ Live! #78 recorded 25 April 2024\" class=\"wp-image-268\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQMLive_78__On_Demand_Knowledge_Center-1024x576.webp 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQMLive_78__On_Demand_Knowledge_Center-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQMLive_78__On_Demand_Knowledge_Center-768x432.webp 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQMLive_78__On_Demand_Knowledge_Center.webp 1170w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>If you have ever thought to yourself&nbsp;<em>&#8220;I wonder what the notified body is thinking?&#8221;<\/em>&nbsp;&#8230;this is a conversation you want to hear.<\/p>\n\n\n\n<p>The involvement of notified bodies under the previous IVD directive was limited to a small number of analytes and device types. As a result, many IVD manufacturers have never worked with a notified body and are now trying to understand how notified bodies operate and navigate the complex path towards IVDR certification.<\/p>\n\n\n\n<p>In this conversation, Margot Borgel, RQM+ Director of IVD Global Regulatory Affairs, sits down with Head of IVD Notified Body at BSI, Alex Laan. The conversation will explore the inner workings of an IVDR notified body and shine light on how the notified bodies work with other key stakeholders, set expectations for manufacturers, and navigate the constantly changing landscape of IVDR.<\/p>\n\n\n\n<p>By attending this free event, you will gain an understanding of&nbsp;<strong>how the notified body operates<\/strong>, which will allow more confident and informed interactions as you move through IVDR certification and beyond.<\/p>\n\n\n\n<p>The discussion will include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>How notified bodies interact with competent authorities and other notified bodies<\/li>\n\n\n\n<li>How new guidance and changes to IVDR are implemented within the notified body<\/li>\n\n\n\n<li>How expectations are set and consistency is maintained for IVDR certification<\/li>\n\n\n\n<li>What notified bodies wish manufacturers knew<\/li>\n<\/ul>\n\n\n\n<p>Watch on demand by completing the form on this page.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-10ee1f1f00c0e06dfb83888753fc7b11\">PARTICIPANTS<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">Alex Laan<br>Head of IVD Notified Body, BSI<\/h4>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/04\/1599474626674-1.webp\" alt=\"Alex Laan\" class=\"wp-image-275\" style=\"width:200px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/04\/1599474626674-1.webp 800w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/04\/1599474626674-1-300x300.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/04\/1599474626674-1-150x150.webp 150w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/04\/1599474626674-1-768x768.webp 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p>Alex Laan recently joined BSI as the Head of IVD Notified Body. In this position, Alex will be focusing on further strengthening the regulatory foundations within the IVD team and make BSI future-proof for the years to come in the challenging regulatory environment in the EU for IVD\u2019s.&nbsp;<\/p>\n\n\n\n<p>Alex is originally a biochemical engineer and worked on the design and development of ELISA based assays in virology and immunohematology tests. He has worked a technical specialist in reagents and tests at Sanquin blood bank located in Amsterdam.&nbsp;<\/p>\n\n\n\n<p>He holds degrees in Biomedical Chemistry, Biotechnology and Business Administration.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Margot Borgel<br>Director of IVD Global Regulatory Affairs, RQM+<\/h4>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/margot_headshot.webp\" alt=\"margot_headshot\" class=\"wp-image-198\" style=\"width:200px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/margot_headshot.webp 500w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/margot_headshot-300x300.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/margot_headshot-150x150.webp 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/figure>\n\n\n\n<p>Margot Borgel, Ph.D. is the Director for IVD Global Regulatory Affairs at RQM+ where she provides her expertise in IVDR implementation and notified body requirements. Prior to RQM+, Margot was a Technical Specialist at BSI, where she performed technical reviews for IVDR, IVDD and UKCA certification. She is especially passionate about certification of high-risk devices and enjoyed seeing these devices through IVDR certification while at BSI. Before her notified body work, Margot worked for Immucor, Inc. where she held roles in R&amp;D, manufacturing technical support and manufacturing.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you have ever thought to yourself&nbsp;&#8220;I wonder what the notified body is thinking?&#8221;&nbsp;&#8230;this is a conversation you want to&#8230;<\/p>\n","protected":false},"author":2,"featured_media":161,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-204","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan","link":"https:\/\/www.rqmplus.com\/resources\/behind-the-scenes-with-bsi-head-of-ivd-notified-body-alex-laan\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/philippe-spitalier-kA9901YPOCk-unsplash-Copy-min.jpg","excerpt":"If you have ever thought to yourself&nbsp;&#8220;I wonder what the notified body is thinking?&#8221;&nbsp;&#8230;this is a conversation you want to...","display_date":"April 25, 2024"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Inside IVDR Certification: Insights from Alex Laan at BSI | RQM+<\/title>\n<meta name=\"description\" content=\"Watch our on-demand discussion with Alex Laan, Head of IVD Notified Body at BSI, as he provides insights into the inner workings of an IVDR notified body and offers guidance for manufacturers navigating IVDR certification.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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