{"id":222,"date":"2023-02-16T11:33:00","date_gmt":"2023-02-16T17:33:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=222"},"modified":"2025-07-16T08:32:54","modified_gmt":"2025-07-16T13:32:54","slug":"the-evolving-biocompatibility-landscape-staying-ahead-of-regulatory-requirements","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/the-evolving-biocompatibility-landscape-staying-ahead-of-regulatory-requirements\/","title":{"rendered":"The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements"},"content":{"rendered":"\n<p>On Thursday, 16 February 2023, RQM+ subject matter experts hosted episode #64 of our Live! show.&nbsp;<strong>Fill out the form to get access to the on-demand recording now.<\/strong><\/p>\n\n\n\n<p>Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different <a href=\"https:\/\/www.rqmplus.com\/solutions\/regulatory-quality\/\">regulatory bodies<\/a> have different expectations when evaluating this data.\u00a0Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing.<\/p>\n\n\n\n<p>The expert panel will:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Describe how chemical characterization, toxicological risk assessment and biological testing work together to evaluate a device<\/li>\n\n\n\n<li>Explain how to ensure method sensitivity, maximize quantitative accuracy and identification confidence<\/li>\n\n\n\n<li>Highlight which validation experiments are expected for chemical characterization<\/li>\n\n\n\n<li>Discuss the major points of departure between European notified bodies and US FDA<\/li>\n\n\n\n<li>Explain which certifications are necessary for laboratories<\/li>\n\n\n\n<li>Show how controls used, and when are they necessary in biological testing<\/li>\n\n\n\n<li>Evaluate how revisions to ISO 10993-17 may impact toxicological risk assessment<\/li>\n<\/ul>\n\n\n\n<p>Panelists:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Joel M. Cohen, Sc.D., DABT \u2013 Principal, Gradient &nbsp;<\/li>\n\n\n\n<li>Jaishankar (Jai) Kutty, Ph.D. \u2013 Vice President, Intelligence &amp; Innovation, RQM+<\/li>\n\n\n\n<li>Kevin Rowland \u2013 Director of R&amp;D, RQM+<\/li>\n\n\n\n<li>Taryn Meade \u2013 Director of Biological Evaluation Consulting, RQM+<\/li>\n\n\n\n<li>Nancy Morrison, RAC \u2013 Vice President, Intelligence &amp; Innovation, RQM+ (moderator)<\/li>\n<\/ul>\n\n\n\n<p>Please sign up to access the recording by filling out the form.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Thursday, 16 February 2023, RQM+ subject matter experts hosted episode #64 of our Live! show.&nbsp;Fill out the form to&#8230;<\/p>\n","protected":false},"author":2,"featured_media":157,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-222","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements","link":"https:\/\/www.rqmplus.com\/resources\/the-evolving-biocompatibility-landscape-staying-ahead-of-regulatory-requirements\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","excerpt":"On Thursday, 16 February 2023, RQM+ subject matter experts hosted episode #64 of our Live! show.&nbsp;Fill out the form to...","display_date":"February 16, 2023"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - 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