{"id":176,"date":"2024-11-21T08:05:00","date_gmt":"2024-11-21T14:05:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=176"},"modified":"2025-07-09T06:29:53","modified_gmt":"2025-07-09T11:29:53","slug":"rsvp-live-84-critical-shifts-in-biological-evaluation","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/rsvp-live-84-critical-shifts-in-biological-evaluation\/","title":{"rendered":"Critical Shifts in Biological Evaluation:\u00a0Inside the New ISO 10993-1 Risk Management Framework"},"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\/RQMLive_84_On_Demand.webp\" alt=\"Recorded 21 November 2024 Critical Shifts in Biological Evaluation Inside the New ISO 10993-1 Risk Management Framework Live #84\" class=\"wp-image-177\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQMLive_84_On_Demand.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQMLive_84_On_Demand-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/RQMLive_84_On_Demand-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p><em>Available on demand.<\/em><\/p>\n\n\n\n<p>As significant changes to ISO 10993-1 loom on the horizon, manufacturers across MedTech are seeking clarity on what&#8217;s coming and how to prepare. Join our expert panel for an essential discussion on these upcoming revisions to ISO 10993-1 and their far-reaching implications for biological evaluation processes.&nbsp;<\/p>\n\n\n\n<p>Our panel will provide actionable insights into:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The most significant upcoming changes to ISO 10993-1 and their implementation timeline<\/li>\n\n\n\n<li>Comprehensive guidance on applying the ISO 14971 device risk management framework to biological evaluation, including:\n<ul class=\"wp-block-list\">\n<li>New approaches to risk estimation<\/li>\n\n\n\n<li>Considerations for reasonably foreseeable misuse<\/li>\n\n\n\n<li>Practical implementation strategies<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Critical updates to device categorization and their impact on modified biological effects<\/li>\n\n\n\n<li>Strategic considerations for maintaining compliance during this transition\u00a0<\/li>\n<\/ul>\n\n\n\n<p><strong>Who Should Attend:<\/strong>&nbsp;This session is essential for regulatory affairs professionals, quality managers, and R&amp;D teams involved in medical device development and biological safety assessment. Whether you&#8217;re preparing for upcoming changes or seeking to optimize your current processes, this discussion will provide actionable insights for maintaining compliance and efficiency.&nbsp;<\/p>\n\n\n\n<p><strong>Panelists:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Taryn Meade \u2013 Director of Biological Evaluation<\/li>\n\n\n\n<li>Stephen Bond \u2013 Senior Toxicologist<\/li>\n\n\n\n<li>Amanda DeGraw, MS, Ph.D., DABT \u2013 Principal Toxicologist<\/li>\n<\/ul>\n\n\n\n<p><strong>Moderator:<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Christine Santagate, RAC \u2013 Vice President of Lab Services\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Register now to gain critical insights into these industry-shifting changes and ensure your organization is prepared for what the transcript reveals to be &#8220;one of the major changes in the standard&#8221; &#8211; the requirement to apply device risk management to biological evaluation.&nbsp;<\/p>\n\n\n\n<p><em>Certificate of Participation available upon request for live attendees.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Available on demand. As significant changes to ISO 10993-1 loom on the horizon, manufacturers across MedTech are seeking clarity on&#8230;<\/p>\n","protected":false},"author":2,"featured_media":1435,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[],"class_list":["post-176","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live"],"acf":[],"card_info":{"title":"Critical Shifts in Biological Evaluation:\u00a0Inside the New ISO 10993-1 Risk Management Framework","link":"https:\/\/www.rqmplus.com\/resources\/rsvp-live-84-critical-shifts-in-biological-evaluation\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/scientist-wearing-protective-gear-examining-samples-under-a-microscope-in-a-laboratory.-5726834-scaled.jpg","excerpt":"Available on demand. 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