{"id":219,"date":"2023-04-27T11:33:00","date_gmt":"2023-04-27T16:33:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=219"},"modified":"2025-06-05T15:52:22","modified_gmt":"2025-06-05T20:52:22","slug":"pragmatic-and-compliant-approaches-to-clinical-evidence","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/pragmatic-and-compliant-approaches-to-clinical-evidence\/","title":{"rendered":"Pragmatic and Compliant Approaches to Clinical Evidence"},"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\/2024\/05\/rqm_live_66_on_demand_promo.webp\" alt=\"on demand recorded 27 April 2023 pragmatic and compliant approaches to clinical evidence live #66\" class=\"wp-image-258\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/rqm_live_66_on_demand_promo.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/rqm_live_66_on_demand_promo-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/rqm_live_66_on_demand_promo-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p>What type of evidence is considered sufficient to comply with the MDR? While we&#8217;ve spoken about this extensively in the past, we explore&nbsp;<em>more<\/em>&nbsp;ways to arrive at the answer and address&nbsp;<em>many<\/em>&nbsp;more questions in this RQM+ Live! show recorded 27 April! We were asked for this topic and we have plenty we&#8217;re excited to share.<br><br>Perhaps in certain situations you&#8217;re asking yourself,&nbsp;<em>&#8220;What kind of clinical evidence do I need for my device?&#8221;<\/em><\/p>\n\n\n\n<p>Our seasoned panelists shared ways to determine exactly that by sharing recent thought processes and examples. We set the tone upfront with a list of factors that affect the &#8216;definition&#8217; of sufficient clinical data, generally speaking: intended purpose, novelty, benefit-risk profiles, number of indications, users, where it&#8217;s used in the world and supportive non-clinical data&#8230; just to name a few.<\/p>\n\n\n\n<p>More specifics on what this session covered:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Less burdensome, yet effective ways to comply with clinical requirements, using examples from a variety of device types<\/li>\n\n\n\n<li>How do you collect clinical data for standard of care devices?<\/li>\n\n\n\n<li>How and when can you use Article 61(10) and what is an indirect benefit? Does it make sense for software devices?<\/li>\n\n\n\n<li>Is equivalence really no longer useable for Class III and implantable devices?<\/li>\n\n\n\n<li>Why monitoring the SOTA could potentially save your company from wasting resources and is much more than just another regulatory requirement<\/li>\n\n\n\n<li>Evidence for Annex XVI products (products with no intended medical purpose)<\/li>\n<\/ul>\n\n\n\n<p>This was a loaded session that our team was incredibly excited about! We tried to provide as much actionable value as possible.<\/p>\n\n\n\n<p>Panelists:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Amie Smirthwaite, BEng, Ph.D. \u2013 Senior Vice President, Intelligence &amp; Innovation<\/li>\n\n\n\n<li>Jon Gimbel, Ph.D. \u2013 Vice President, Technical<\/li>\n\n\n\n<li>Bethany Chung, Ph.D., RAC \u2013 Principal<\/li>\n\n\n\n<li>Sally Sennitt \u2013 Medical Director, Intelligence and Innovation<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>What type of evidence is considered sufficient to comply with the MDR? While we&#8217;ve spoken about this extensively in the&#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-219","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"Pragmatic and Compliant Approaches to Clinical Evidence","link":"https:\/\/www.rqmplus.com\/resources\/pragmatic-and-compliant-approaches-to-clinical-evidence\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","excerpt":"What type of evidence is considered sufficient to comply with the MDR? 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