{"id":216,"date":"2023-07-27T11:33:00","date_gmt":"2023-07-27T16:33:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=216"},"modified":"2025-06-05T15:51:58","modified_gmt":"2025-06-05T20:51:58","slug":"insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","title":{"rendered":"Insider Perspectives: Mastering EU Compliance with BSI&#8217;s Richard Holborow and RQM+&#8217;s Amie Smirthwaite"},"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\/live_69_on_demand.webp\" alt=\"recorded 27 July 2023 insider perspectives: mastering eu compliance with bsi's richard holborow and RQM+'s amie smirthwaite live #69\" class=\"wp-image-253\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_69_on_demand.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_69_on_demand-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/live_69_on_demand-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p>Join us for what will surely be a captivating and informative conversation aiming to help you&nbsp;<strong>master EU compliance<\/strong>, where BSI&#8217;s Global Head Clinical Compliance Richard Holborow and RQM+&#8217;s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together to address current challenges and provide valuable insights on navigating the complex landscape of EU regulations.<\/p>\n\n\n\n<p>This conversation will:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Empower manufacturers<\/strong><\/li>\n\n\n\n<li><strong>Alleviate fears<\/strong><\/li>\n\n\n\n<li><strong>Equip manufacturers with practical guidance to succeed in the European market<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Richard and Amie at a glance&#8230;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Richard: Unparalleled insider knowledge from renowned notified body BSI, sharing exclusive industry insights<\/li>\n\n\n\n<li>Amie: Seasoned\u00a0regulatory professional\u00a0and former notified body leader, with extensive manufacturer feedback and practical experience<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-278603e6f86d316b1a790dc7d8162bca\">Key Topics of Discussion<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Notified body capacity<\/strong>: Current status and future outlook, with insights into the impact of regulation 2022-14 and collaborative efforts among notified bodies<\/li>\n\n\n\n<li><strong>Overcoming challenges<\/strong>: Strategies for both legacy and new devices, ensuring successful market access and maintaining a robust product pipeline in Europe<\/li>\n\n\n\n<li><strong>Streamlining the certification journey<\/strong>: Easy fixes manufacturers can implement to improve submissions, enhance the certification process, and simplify their path to compliance<\/li>\n\n\n\n<li><strong>Certificates\u00a0with\u00a0<\/strong><strong>conditions<\/strong>: Latest developments, common challenges, and guidance on effective approaches<\/li>\n\n\n\n<li><strong>And more!<\/strong>\u00a0Additional insights and topics to provide a comprehensive understanding of EU regulations, including answering\u00a0<em>your<\/em>\u00a0questions!<br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-514d7db10cbfc0b0fd65617b9d869fe5\">Benefits for Attendees<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gain exclusive insights and industry knowledge from insiders<\/li>\n\n\n\n<li>Demystify EU regulations and alleviate fears<\/li>\n\n\n\n<li>Obtain practical guidance to navigate the European market successfully<\/li>\n\n\n\n<li>Learn actionable strategies to enhance submissions and streamline the certification process<\/li>\n\n\n\n<li>Stay updated on certifications and conditions<br><\/li>\n<\/ul>\n\n\n\n<p>Don&#8217;t miss your chance to join Richard and Amie in what we expect to be an enlightening conversation, and one that promises to clarify EU regulations and empower manufacturers to thrive.<\/p>\n\n\n\n<p>Register now to secure your spot!<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-abe6a330b5e013edd5b600eb55a49e2c\">More About Richard and Amie<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">Richard Holborow \u2013 Head of Clinical Compliance, BSI<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"430\" height=\"430\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/richard_square_v2-min.webp\" alt=\"richard_square_v2-min\" class=\"wp-image-297\" style=\"width:200px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/richard_square_v2-min.webp 430w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/richard_square_v2-min-300x300.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/richard_square_v2-min-150x150.webp 150w\" sizes=\"(max-width: 430px) 100vw, 430px\" \/><\/figure>\n\n\n\n<p>Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Amie Smirthwaite \u2013 Sr. VP of Intelligence &amp; Innovation, RQM+<\/h3>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"430\" height=\"430\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/Amie-Smirthwaite-Headshot-2022_White_square-min-1.webp\" alt=\"Amie Smirthwaite Headshot 2022_White_square-min (1)\" class=\"wp-image-298\" style=\"width:200px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/Amie-Smirthwaite-Headshot-2022_White_square-min-1.webp 430w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/Amie-Smirthwaite-Headshot-2022_White_square-min-1-300x300.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2023\/07\/Amie-Smirthwaite-Headshot-2022_White_square-min-1-150x150.webp 150w\" sizes=\"(max-width: 430px) 100vw, 430px\" \/><\/figure>\n\n\n\n<p>Dr. Amie Smirthwaite is the Senior Vice President of Intelligence and Innovation at RQM+ and joined the company in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. &nbsp;<\/p>\n\n\n\n<p>She is leading the RQM+ Intelligence and Innovation team, following her role as former Global Head of Clinical Compliance at BSI. Amie developed BSI\u2019s clinical compliance team and lead clinical aspects of BSI\u2019s successful MDR designation and has contributed to numerous clinical and regulatory guidance documents and training.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Join us for what will surely be a captivating and informative conversation aiming to help you&nbsp;master EU compliance, where BSI&#8217;s&#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-216","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"Insider Perspectives: Mastering EU Compliance with BSI&#8217;s Richard Holborow and RQM+&#8217;s Amie Smirthwaite","link":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","excerpt":"Join us for what will surely be a captivating and informative conversation aiming to help you&nbsp;master EU compliance, where BSI&#8217;s...","display_date":"July 27, 2023"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+<\/title>\n<meta name=\"description\" content=\"Watch our on-demand panel discussion featuring BSI&#039;s Global Head of Clinical Compliance, Richard Holborow, and RQM+&#039;s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+\" \/>\n<meta property=\"og:description\" content=\"Watch our on-demand panel discussion featuring BSI&#039;s Global Head of Clinical Compliance, Richard Holborow, and RQM+&#039;s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/\" \/>\n<meta property=\"og:site_name\" content=\"RQM+\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RQMplus\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-05T20:51:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1800\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@RQMplus\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/\",\"url\":\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/\",\"name\":\"Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+\",\"isPartOf\":{\"@id\":\"https:\/\/www.rqmplus.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg\",\"datePublished\":\"2023-07-27T16:33:00+00:00\",\"dateModified\":\"2025-06-05T20:51:58+00:00\",\"description\":\"Watch our on-demand panel discussion featuring BSI's Global Head of Clinical Compliance, Richard Holborow, and RQM+'s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg\",\"width\":1800,\"height\":1200,\"caption\":\"Pulse monitor on someone's finger.\"},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rqmplus.com\/#website\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"name\":\"RQM+\",\"description\":\"Evolving MedTech\",\"publisher\":{\"@id\":\"https:\/\/www.rqmplus.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rqmplus.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.rqmplus.com\/#organization\",\"name\":\"RQM+\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"width\":696,\"height\":696,\"caption\":\"RQM+\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/RQMplus\",\"https:\/\/x.com\/RQMplus\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+","description":"Watch our on-demand panel discussion featuring BSI's Global Head of Clinical Compliance, Richard Holborow, and RQM+'s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","og_locale":"en_US","og_type":"article","og_title":"Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+","og_description":"Watch our on-demand panel discussion featuring BSI's Global Head of Clinical Compliance, Richard Holborow, and RQM+'s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.","og_url":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","og_site_name":"RQM+","article_publisher":"https:\/\/www.facebook.com\/RQMplus","article_modified_time":"2025-06-05T20:51:58+00:00","og_image":[{"width":1800,"height":1200,"url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_site":"@RQMplus","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","url":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/","name":"Mastering EU Compliance: Insights from BSI and RQM+ Experts | RQM+","isPartOf":{"@id":"https:\/\/www.rqmplus.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage"},"image":{"@id":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage"},"thumbnailUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","datePublished":"2023-07-27T16:33:00+00:00","dateModified":"2025-06-05T20:51:58+00:00","description":"Watch our on-demand panel discussion featuring BSI's Global Head of Clinical Compliance, Richard Holborow, and RQM+'s Senior Vice President of Intelligence and Innovation, Amie Smirthwaite, as they provide valuable insights on navigating the complex landscape of EU regulations.","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/resources\/insider-perspectives-mastering-eu-compliance-with-bsis-richard-holborow-and-rqms-amie-smirthwaite\/#primaryimage","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","width":1800,"height":1200,"caption":"Pulse monitor on someone's finger."},{"@type":"WebSite","@id":"https:\/\/www.rqmplus.com\/#website","url":"https:\/\/www.rqmplus.com\/","name":"RQM+","description":"Evolving MedTech","publisher":{"@id":"https:\/\/www.rqmplus.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rqmplus.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.rqmplus.com\/#organization","name":"RQM+","url":"https:\/\/www.rqmplus.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","width":696,"height":696,"caption":"RQM+"},"image":{"@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RQMplus","https:\/\/x.com\/RQMplus"]}]}},"_links":{"self":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/scb-resources\/216","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/scb-resources"}],"about":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/types\/scb-resources"}],"author":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":0,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/scb-resources\/216\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media\/157"}],"wp:attachment":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media?parent=216"}],"wp:term":[{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/resource-type?post=216"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/topic?post=216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}