{"id":182,"date":"2024-10-04T09:20:00","date_gmt":"2024-10-04T14:20:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=182"},"modified":"2025-06-05T15:46:20","modified_gmt":"2025-06-05T20:46:20","slug":"structured-dialogue-how-to-engage-with-notified-bodies","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/structured-dialogue-how-to-engage-with-notified-bodies\/","title":{"rendered":"Structured Dialogue:\u00a0How to Engage with Notified Bodies"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"960\" height=\"540\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQM_Live_83_On_Demand.webp\" alt=\"Recorded 4 October 2024 Structured Dialogue How to Engage with Notified Bodiev Live #83\" class=\"wp-image-183\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQM_Live_83_On_Demand.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQM_Live_83_On_Demand-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQM_Live_83_On_Demand-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p><em>Featuring guests from BSI, T\u00dcV S\u00dcD, and GMED<\/em><\/p>\n\n\n\n<p>Live! #83 presentation and panel\u00a0 |\u00a0 Recorded 4 October 2024<\/p>\n\n\n\n<p><em><strong>Available on demand.<\/strong><\/em><\/p>\n\n\n\n<p>Join us for an exclusive panel discussion featuring top experts from T\u00dcV S\u00dcD, GMED, and BSI as they dive into the intricacies of structured dialogue between MedTech manufacturers and notified bodies. As regulatory expectations continue to evolve under MDR and IVDR, these dialogues are vital for ensuring compliance and expediting market access.\u00a0<\/p>\n\n\n\n<p>Our panelists will provide valuable insights into key topics such as:\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Effective strategies for engaging with notified bodies in structured dialogues<\/li>\n\n\n\n<li>Managing device classifications, submission processes, and project timelines<\/li>\n\n\n\n<li>How to navigate changes in notified bodies and maintain compliance<\/li>\n\n\n\n<li>Best practices for developing regulatory plans in new technology areas\u00a0<\/li>\n<\/ul>\n\n\n\n<p>This session is ideal for regulatory professionals, quality assurance teams, and MedTech manufacturers seeking practical guidance on optimizing their interactions with notified bodies.&nbsp;<\/p>\n\n\n\n<p>Don&#8217;t miss this opportunity to learn from leading voices in the industry and gain actionable strategies to ensure regulatory success. This session will be invaluable for anyone navigating MDR\/IVDR compliance. Register today to secure your spot!&nbsp;<\/p>\n\n\n\n<p><strong>Panelists:<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Alex Laan \u2013 Head of the IVD Notified Body, BSI<\/li>\n\n\n\n<li>Dr. Andreas Stange\u00a0\u2013\u00a0Senior Vice President MHS Regulatory &amp; Quality,\u00a0T\u00dcV S\u00dcD<\/li>\n\n\n\n<li>Tom Patten\u00a0\u2013\u00a0IVDR\/IVD International Manager, GMED\u00a0<\/li>\n<\/ul>\n\n\n\n<p><strong>Moderator:<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Jaishankar (Jai) Kutty, Ph.D. \u2013 Vice President, Global Regulatory Affairs, RQM+\u00a0<\/li>\n<\/ul>\n\n\n\n<p><em>Certificate of Participation available upon request for live attendees.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Featuring guests from BSI, T\u00dcV S\u00dcD, and GMED Live! #83 presentation and panel\u00a0 |\u00a0 Recorded 4 October 2024 Available 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