{"id":27343,"date":"2026-09-21T15:22:29","date_gmt":"2026-09-21T19:22:29","guid":{"rendered":"https:\/\/themedtechconference.com\/?p=27343"},"modified":"2026-09-21T15:25:29","modified_gmt":"2026-09-21T19:25:29","slug":"mtc26-keynote-hear-directly-from-senior-fda-cdrh-leaders","status":"publish","type":"post","link":"https:\/\/themedtechconference.com\/mtc26-keynote-hear-directly-from-senior-fda-cdrh-leaders\/","title":{"rendered":"MTC26 Keynote: Hear Directly from Senior FDA CDRH Leaders"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Join senior leaders from the U.S. Food and Drug Administration\u2019s Center for Devices and Radiological Health (CDRH) at The MedTech Conference, October 18\u201321 in Boston, for a direct conversation on CDRH\u2019s strategic direction, regulatory priorities, and what\u2019s ahead for the medtech industry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This Wednesday Keynote Breakfast will provide an inside look at the issues shaping the regulatory landscape, with senior CDRH leadership sharing perspectives on digital health, regulatory policy, science and engineering, strategic partnerships, and the center\u2019s broader priorities for medical devices and diagnostics.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Hear from CDRH Leaders about:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The center\u2019s current strategic priorities and areas of focus<\/li>\n\n\n\n<li>Evolving regulatory considerations for digital health and emerging technologies<\/li>\n\n\n\n<li>Updates on regulatory policy and approaches to medical device evaluation<\/li>\n\n\n\n<li>How science, engineering and technology innovation are informing CDRH\u2019s work<\/li>\n\n\n\n<li>Opportunities for collaboration and strategic partnerships between CDRH and the medtech community<\/li>\n\n\n\n<li>What medtech companies should be watching as the regulatory landscape continues to evolve<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/themedtechconference.com\/register\/\">REGISTER now<\/a><\/div>\n<\/div>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-1024x576.png\" alt=\"\" class=\"wp-image-27345\" srcset=\"https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-1024x576.png 1024w, https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-400x225.png 400w, https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-200x113.png 200w, https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-768x432.png 768w, https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-1536x864.png 1536w, https:\/\/themedtechconference.com\/wp-content\/uploads\/MTC26KeynoteGraphicsTemplate_PPTX_1920x1080-6-2048x1152.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center\">The Latest Medtech Regulatory Insights, All in One Place<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory strategy is a critical part of advancing innovation in medtech. Across the #MTC26 education program, leaders will explore the evolving regulatory landscape, emerging technologies, policy developments, and the practical considerations shaping how new products move from development to market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With regulatory experts, medtech executives, policy leaders, innovators, and industry partners all in one place, the conversations extend well beyond the session rooms, creating opportunities to exchange perspectives, understand what\u2019s evolving, and build relationships across the industry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory sessions already generating excitement:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><a href=\"https:\/\/themedtechconference.com\/2026-schedule\/?utm_campaign=22804503-2026+The+MedTech+Conference&amp;utm_medium=email&amp;_hsenc=p2ANqtz--Hvs6wSIyiSzEWVgrj0in7Qk6FVX0aoNf3XvMbBmxHOOZCWGmp5XiKVbb1ef0Fg-9eqzBYJIGPOGGD_4TNmsliMA1M-A&amp;_hsmi=439668385&amp;utm_content=439668385&amp;utm_source=hs_email&amp;schedule_preset=session%3A3535150%3Asearch%3Aregulatory\"><strong>Lessons from Year 1 of QMSR Implementation: What\u2019s Next for Aligning Quality Systems, ISO 13485, Inspection Readiness, and Compliance<\/strong><\/a><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Jamie Wolszon, Vice President, Technology &amp; Regulatory Affairs, <strong>AdvaMed<\/strong><\/li>\n\n\n\n<li>Douglas Reimer, Senior Director, Regulatory Compliance, <strong>Johnson &amp; Johnson Vision<\/strong><\/li>\n\n\n\n<li>Keisha Thomas, Associate Director for Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), CDRH, <strong>U.S. Food and Drug Administration<\/strong><\/li>\n<\/ul>\n\n\n\n<ol start=\"2\" class=\"wp-block-list\">\n<li><a href=\"https:\/\/themedtechconference.com\/2026-schedule\/?utm_campaign=22804503-2026+The+MedTech+Conference&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_QRvHlLlpZRkUXWPnToKtnpXnkoI84yIILNRAJ5C3XRd5xqGsuNm7c7So7SEPkWDnidGeGWfUX33JsjHCDLstRvpwANg&amp;_hsmi=439668385&amp;utm_content=439668385&amp;utm_source=hs_email&amp;schedule_preset=session%3A3535151%3Atags%3Atrack-regulatory-quality-and-good-manufacturing-practices\"><strong>Regulator Perspectives: Advancing Global Harmonization to Accelerate Access to Medtech<\/strong><\/a><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Melissa Torres, Executive Vice President, Technology &amp; Regulatory Affairs, AdvaMed<\/li>\n\n\n\n<li>Raymond Chua, CEO, <strong>Health Sciences Authority<\/strong><\/li>\n\n\n\n<li>Kenichi Ishibashi, Senior Scientist, Office of Compliance and Manufacturing Quality for Medical Devices, <strong>Pharmaceuticals and Medical Devices Agency (PMDA)<\/strong><\/li>\n\n\n\n<li>Kenneth Cavanaugh Jr., PhD., Associate Director for International Policy and Strategy, Office of the Center Director, CDRH, <strong>U.S. Food and Drug Administration<\/strong><\/li>\n\n\n\n<li>Vivian Cardoso Morais de Oliveira, General Manager of the General Management of Health Products Technology, <strong>ANVISA &#8211; Brazilian Health Regulatory Agency<\/strong><\/li>\n\n\n\n<li>Sally Prawdzik, Director, Policy and International Programs, <strong>Health Canada<\/strong><\/li>\n\n\n\n<li>Freya Rowland, Head of Innovative Devices Strategy and International,<strong> U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)<\/strong><\/li>\n<\/ul>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li><a href=\"https:\/\/themedtechconference.com\/2026-schedule\/?utm_campaign=22804503-2026+The+MedTech+Conference&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_V_Gn3wOPmA2ipBLCyfUdx1Il28YWrw7xyXUJOyqKPQfNMVHJtYetKylC6FfzXD6YFJzDFpTtPPMHKZReOSQ0IxtpU-g&amp;_hsmi=439668385&amp;utm_content=439668385&amp;utm_source=hs_email&amp;schedule_preset=session%3A3490695%3Atags%3Atrack-regulatory-quality-and-good-manufacturing-practices\"><strong>FDA&#8217;s De Novo Program: Exploring Opportunities for Increased Engagement<\/strong><\/a><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Joshua Nipper, ME, Director, Division of Regulatory Programs 1 (Submission Support), <strong>U.S. Food and Drug Administration<\/strong><\/li>\n\n\n\n<li>Joshua Silverstein, Director, Regulatory Policy &amp; Intelligence Americas, <strong>Stryker<\/strong><\/li>\n\n\n\n<li>Geeta Pamidimukkala, Vice President, Technology and Regulatory Affairs, <strong>AdvaMed<\/strong><\/li>\n<\/ul>\n\n\n\n<ol start=\"4\" class=\"wp-block-list\">\n<li><a href=\"https:\/\/themedtechconference.com\/2026-schedule\/?utm_campaign=22804503-2026+The+MedTech+Conference&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8khRUqF2BCvgGzOgmdVzza21gbQkxFcVngW9YNRn2QyDWSJ3qUogIB8nxiCIdLd0IVKW74V09xuUO32S4pWNn4qf0-XQ&amp;_hsmi=439668385&amp;utm_content=439668385&amp;utm_source=hs_email&amp;schedule_preset=session%3A3535148%3Atags%3Atrack-regulatory-quality-and-good-manufacturing-practices\"><strong>Advancing Global Regulatory Convergence: Enabling Innovation and Patient Access<\/strong><\/a><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nicole Taylor Smith, JD, Head of Regulatory Affairs and Policy, <strong>Philips<\/strong><\/li>\n\n\n\n<li>Kenneth Cavanaugh Jr., PhD., Associate Director for International Policy and Strategy, Office of the Center Director, CDRH, <strong>U.S. Food and Drug Administration<\/strong><\/li>\n\n\n\n<li>Diane Wurzburger, RAC, Vice President, Global Regulatory Intelligence and Policy, <strong>GE HealthCare<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These four sessions are just a preview of what you&#8217;ll find at #MTC26. With more than 400 expert speakers and 20+ timely topics, the education program delivers actionable insights on the trends, challenges, and opportunities shaping the future of medtech. Join us next month in Boston, October 18-21.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-space-between is-layout-flex wp-container-core-buttons-is-layout-cfe5ce44 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/themedtechconference.com\/register\/\">REGISTER TODAY<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/themedtechconference.com\/2026-schedule\/\">2026 EDUCATION AGENDA<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Senior leaders from the FDA\u2019s Center for Devices and Radiological Health (CDRH) will headline the Wednesday Breakfast Keynote at The MedTech Conference, October 18\u201321 in Boston. Hear directly from CDRH leadership on regulatory priorities, digital health, emerging technologies, and what\u2019s ahead for medtech, plus explore the broader #MTC26 regulatory program.<\/p>\n","protected":false},"author":45,"featured_media":27346,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[45,44],"tags":[141,135,124,139,51,125,105,109],"class_list":["post-27343","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-announcements","category-events-news","tag-attend","tag-boston","tag-conference-planning","tag-keynote","tag-medtech","tag-medtech-conference","tag-mtc26","tag-update"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MTC26 Keynote: Hear Directly from Senior FDA CDRH Leaders - The MedTech 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