Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements. Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified Body’s expectations. In this free webinar, we will discuss new European PMS and PMCF requirements.
What will you learn:
- Clinical evaluation process in the post-market phase of the device
- The role of clinical data during the lifetime of a medical device
- The purpose of PMS in the MDR and how to perform it
- Why, when, and how to perform PMCF
- Tips, tricks, and pitfalls of PMS and PMCF under the MDR
ABOUT THE PRESENTER:
Ronald Boumans is a Senior Regulatory Consultant at Emergo's office in The Hague with 30+ years of experience in the medical device industry. Prior to joining Emergo, he served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGZ). Ronald’s expertise includes European medical device legislation, Competent Authority supervision, and CE Marking requirements. He is a member of the EUDAMED Steering Committee and the EUDAMED post-market surveillance, vigilance, and data exchange working groups.