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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
After the announcement of medical device regulation (MDR)and a deadline extension, the EU market is bracing for the new requirements. Now facing the possibility of another extension, industry doesn’t even know if or when it must comply.
MDR by the numbers now:
8,120—the number of applications.
1,990—the number of certificates issued.
7000—the number of certificates that may be issued in total by May 2024.
22,793—the number of certificates under medical device directives (MDD) set to expire by May 2024.
425,000—the number of devices under said MDD certificates that will be unavailable after May 2024 without drastic and immediate action.
This webinar looks at MDR implementation by the cold, hard, numbers. The webinar presents the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with stakeholders regarding their first-hand experiences with implementation.
At the conclusion of this workshop, participants should know:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Medical Device Regulatory Professionals and Industry
Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services—and grief counseling, because dealing with regulators can be emotionally draining! Lott served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee. She holds a BS in chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.
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