十二月 09, 2020 - 十二月 09, 2020
Date: December 9th, 2020
Time: 10am PST | 1pm EST
Introduction: The new MDR deadline is fast approaching (again) and device manufacturers are struggling to understand what changes they must make in order to comply with the new regulations. In this webinar presentation, attendees will be presented with practical approaches to the development and execution of PMCF activities, informed by common findings and expert advice. This session will also discuss when it is possible to justify not conducting specific PMCF activities, which will save your team time, money and countless headaches.
Identify & create device appropriate PMCF plans
Understand & avoid common mistakes made in PMCF procedures & plans
Understand when PMCF is and is not required, and be able to justify this decision
Strategize for PMCF execution
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 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. Her broad and multi-faceted experience, enthusiasm for regulatory compliance and communication skills make her an effective project manager and engaging trainer.