MDR Post-Market Clinical Follow-up: Ensure Compliance
The new EU Medical Device Regulation (MDR) deadline is fast approaching (again) and medical device manufacturers are struggling to understand what changes they must make in order to comply with the new EU MDR regulations. In this on-demand webinar presentation, with Mindy McCann, attendees will be presented with practical approaches to the development and execution of MDR post-market clinical follow-up activities, informed by common findings and expert advice. This session will also discuss when it is possible to justify not conducting specific MDR post-market clinical follow-up (PMCF) activities, which in that case will help save your team time, money and countless headaches.
On-Demand Webinar Learning Objectives:
- Identify and create device appropriate PMCF plans
- Understand and avoid common mistakes made in PMCF procedures and plans
- Understand when PMCF is and is not required, and be able to justify this decision
- Strategize for PMCF execution
Learn everything you need to know about the EU MDR PMCF process and plans. For more information about Morningside’s language solutions for medical device companies, click here.
About the Speaker:
Mindy McCann is VP of regulatory compliance at Qserve, where she brings decades of experience in medical device international regulatory affairs and quality management. Before joining Qserve, Mindy worked as a development engineer, notified body auditor and technical file reviewer, global certification manager, and as a regulatory and business executive for a wide range of businesses. She applies a practical approach to developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications. Mindy has a degree in Biomedical Engineering from Carnegie Mellon University and a Masters in Chemical Engineering from the University of Delaware.
