EU-MDR Postmarket Surveillance – Webinar Recording/Transcript
EU-MDR Postmarket Surveillance: Best Practices for Medical Device Regulatory, Compliance & Quality Specialists
The EU-MDR’s newest postmarket surveillance (PMS) requirements are more detailed than before. Are you ready to create the multiple product-specific plans and reports required? And do you have a system for keeping them all up to date? These elements are crucial for compliance.
With greater emphasis on confirming safety and performance throughout your device’s lifetime, you’ll need to be more proactive with your PMS activities than before, including your postmarket clinical follow-up (PMCF). Fail to properly consider PMCF and your Notified Body (NB) is sure to take notice.
Plus, to ensure alignment, all the data you collect needs to be considered in your clinical evaluation report (CER), risk management documents and labeling.
Jon Gimbel, Ph.D., executive director at Regulatory and Quality Solutions, has more than 20 years of experience in medical devices and has been involved in over 100 CERs. He will explain the best practices you need to follow to easily create — and keep up-to-date — product-specific plans and reports.
- Details on the specific data elements that should be included in the Postmarket Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), PMCF report and CER and how the data from various reports can be linked together.
- An overview of an example process that will enable the PMS, PMCF, CER and risks management documentation to be linked and updated together.
- An explanation of how proactive PMS is related to PMS and PMCF and what type of activities are considered PMS vs. PMCF.
- An understanding of the type of objectives of PMCF, such as to confirm safety and performance throughout the lifetime of the device and not to provide sufficient clinical evidence to demonstrate conformity to the applicable General Safety Performance Requirements (GSPRs).
- A discussion of common findings related to PMS and PMCF, such as failure to provide a statistically justified sample size.
Easily master PMS and confirm the safety and performance throughout the lifetime of your medical device. You’ll need to be ready by the May 2021 deadline.
Meet Your Presenter:
Jon Gimbel, Executive Director at Regulatory and Quality Solutions, has a Ph.D. in mechanical engineering and over 20 years of experience in medical devices. He has done regulatory and quality work with small and large companies and has been involved in over 100 CERs. Dr. Gimbel is now using this experience to help companies with performance evaluations. As a consultant, he has been involved in a large variety of projects and has seen how notified bodies review these evaluations.
Who Will Benefit:
- Regulatory Specialists
- Compliance Specialists
- Quality Specialists