Thursday, July 21 | 12pm-1pm ET
In this upcoming paid webinar in partnership with RAPS, Angela Siebeneck, MSN RN, Director of Regulatory Strategy and Policy at Certara | Synchrogenix will be talking through the expectations set by PMCF for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. Together, we will review what may qualify for PMCF, what is required, and when it is required.
A live Q&A portion with Angela will follow the presentation.
This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Upon the conclusion of this webinar, you will:
- Describe what PMCF is and what is expected.
- Learn the types of PMCF for different classes of products.
- Learn how PMCF fits into your regulatory cycle.
Angela Siebeneck, MSN RN
Director of Regulatory Strategy and Policy at Certara | Synchrogenix
Ms. Siebeneck has over 30 years of clinical and device experience. She has written and provided guidance and advice for over 100 clinical evaluation reports for a wide variety of devices. During her career as a nurse she gained deep practical experience with many of the types of devices she has developed and implemented clinical evaluation strategies. She has even written a book on peripherally inserted central catheters (PICC) which provides details on how to insert and care for PICCs and ensure compliance with the recommendations for use.