{"id":209,"date":"2024-01-15T11:32:00","date_gmt":"2024-01-15T17:32:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=209"},"modified":"2025-07-16T08:43:46","modified_gmt":"2025-07-16T13:43:46","slug":"rqmplus-white-paper-ithe-real-cost-of-noncompliance-ivdr","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/rqmplus-white-paper-ithe-real-cost-of-noncompliance-ivdr\/","title":{"rendered":"The Real Cost of Noncompliance: Leveraging IVDR for Long-Term Savings"},"content":{"rendered":"\n<p><em>Leveraging IVDR for Long-Term Savings in the MedTech Industry&nbsp;<\/em><\/p>\n\n\n\n<p>The inherent complexity of <a href=\"https:\/\/www.rqmplus.com\/expertise\/ivd\/\">IVDR<\/a> has left many organizations grappling with implementation issues. Despite these challenges, IVDR compliance can yield substantial long-term cost savings for MedTech companies.\u00a0<\/p>\n\n\n\n<p>This paper explores what IVDR means for the MedTech industry and provides insights on turning compliance into a strategic advantage.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-72fc8207b5bee6549b4641ae70c0ee36\">THIS WHITE PAPER COVERS:&nbsp;<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>What IVDR means for your business<\/li>\n\n\n\n<li>Real-world case studies exploring how manufacturers overcame common IVDR challenges<\/li>\n\n\n\n<li>Lessons for minimizing IVDR costs and accelerating time-to-market<\/li>\n\n\n\n<li>The long-term financial rewards of IVDR compliance<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-ebae9bf4fa4c03b50b7182fa5fb44c0a\">MEET THE AUTHORS:&nbsp;<\/h3>\n\n\n\n<p><strong>MARGOT BORGEL, Ph.D.&nbsp;<\/strong><br><strong>DIRECTOR, IVD INTELLIGENCE AND INNOVATION<\/strong><\/p>\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 is an IVD expert at RQM+&nbsp; who helps her clients in many ways, primarily with 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&#8217;s 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 an IVD manufacturer where she held roles in R&amp;D, manufacturing technical support and manufacturing.<\/p>\n\n\n\n<p><strong>JONATHAN GIMBEL, Ph.D.&nbsp;<br>VICE PRESIDENT, TECHNICAL<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"496\" height=\"496\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/jon-gimbel.webp\" alt=\"jon gimbel\" class=\"wp-image-250\" style=\"width:200px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/jon-gimbel.webp 496w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/jon-gimbel-300x300.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/jon-gimbel-150x150.webp 150w\" sizes=\"(max-width: 496px) 100vw, 496px\" \/><\/figure>\n\n\n\n<p>Dr. Jonathan Gimbel joined RQM+ in July of 2014. He has a Ph.D. in Mechanical Engineering from the University of Pennsylvania and is a clinical and regulatory affairs expert with over 20 years of experience in medical devices. Jonathan has a wide variety of clinical and regulatory experience as an academic researcher, key member of a medical device startup, and medical device consultant. This has given him extensive knowledge of biomedical research, new product development, quality systems, FDA and EU regulatory affairs, clinical evaluation, and post-market surveillance activities. Jonathan is currently the Vice President, Technical within RQM+\u2019s consulting services. In this role, he is actively involved in overseeing the technical aspects of the regulatory, quality, clinical evaluation, and post-market practices at RQM+.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Leveraging IVDR for Long-Term Savings in the MedTech Industry&nbsp; The inherent complexity of IVDR has left many organizations grappling with&#8230;<\/p>\n","protected":false},"author":2,"featured_media":164,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[7],"topic":[9],"class_list":["post-209","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-white-paper","topic-regulatory-quality"],"acf":[],"card_info":{"title":"The Real Cost of Noncompliance: Leveraging IVDR for Long-Term Savings","link":"https:\/\/www.rqmplus.com\/resources\/rqmplus-white-paper-ithe-real-cost-of-noncompliance-ivdr\/","link_target":"_self","name":"White 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