What You Should Know About MDR Best Practices, Including PMCF
Tuesday, July 26, 2022 (1:00 PM - 2:00 PM) (EDT)
The Medical Device Regulation (MDR) 745/2017, published in 2017, established a stricter and more uniform regulatory framework for the European Union with the goal of improving the clinical safety of the devices. Today, all medical devices in Europe must comply with the MDR yet many companies still facing difficulties navigating these new regulations.
In this webinar, sponsored by Alira Health and MassMedic, we will review major changes introduced by the MDR. We will focus on the post-market requirements, especially the Post-Market Clinical Follow-up (PMCF). Our panel of experts will share their experiences with the new MDR regulation and offer best practices for companies in the middle of, or about to start, their own MDR journey.
•Anagha Karnik, Director, Regulatory Affairs at Edwards Lifesciences
•Arthi Chandran, Divisional Vice President, Health Economics and Reimbursement at Abbott
•Sharon Timberlake, Vice President of Clinical, Quality, & Regulatory Affairs at GENTUITY