Strengthen Your IDE Strategy at AdvaMed’s IDE Submissions Workshop
Gain in-depth IDE submission training, meaningful face time with FDA and regulatory leaders, and RAPS accreditation credits at AdvaMed’s IDE Submissions Workshop.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed® Names Brian J. Blaser, QuidelOrtho President and CEO, Chair of AdvaMedDx Board of Directors
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Brian Blaser, president and CEO of QuidelOrtho, will serve as the next chair of the AdvaMedDx Division Board of Directors, succeeding Thierry Bernard, CEO of QIAGEN. AdvaMedDx represents more…
Medical Imaging Division Announces Rich Fabian as New Board Chair
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Rich Fabian, president and CEO of FUJIFILM Sonosite, will serve as the chair of the Medical Imaging division’s board of directors. He will succeed David Pacitti, CEO of Avanos Medical and former president and…
Robert Cohen of Stryker Named Chair of AdvaMed’s Digital Health Tech Division Board of Directors
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Robert Cohen, vice president, innovation and technology, orthopaedic group at Stryker, will be the next chair of theAdvaMed® Digital Health Tech Board of Directors. He…
Mick Farrell, Chairman and CEO of Resmed, Named Chair ofAdvaMed® Board of Directors
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced Michael “Mick” Farrell, chairman and CEO of Resmed Inc. (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in…
Medical Device Submissions Series: Investigational Device Exemption (IDE) Workshop
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Medical Device Submissions Series: Premarket Approval (PMA) Workshop
Learn key PMA Submissions strategies to build a strong submissions, align with FDA expectations, and reduce delays.
Medical Device Submissions Series: 510(k) & De Novo Workshop
Join industry leaders for the in-depth 510(k) & De Novo Workshop for real-world case studies, submissions tips and best practices.
AdvaMed® Urges CMS to Protect Patient Access to Critical Medical Equipment
WASHINGTON — AdvaMed, the MedTech Association®, the world’s largest trade association representing medtech innovators, today released the following statement on the U.S. Centers for Medicare & Medicaid Services’ (CMS) release…
QMSR Transition: Legal and Audit Perspectives
Join Hogan Lovells experts to learn how the FDA is set to reshape the medical device regulatory landscape with the introduction of the QMSR.