September 11, 2022 - September 13, 2022
Date: September 11th - 13th, 2022
Location: Phoenix, AZ, United States
RAPS Convergence is the leading conference for regulatory professionals to connect with peers and interact directly with health authorities and notified bodies on the latest topics in the healthcare products sector. RAPS Convergence provides regulatory professionals key regulatory knowledge and resources on medical devices, IVDs and biopharma to help you successfully navigate today’s regulatory landscape.
Saturday, Sept. 10, 2022
- 8:30 AM – 4:00 PM MST – Mindy McCann and Patrícia da Silva Peres - Preconference Workshop: Clinical Evaluation.
Monday, Sept. 12, 2022
- 9:45 AM – 11:00 AM MST - Gert W. Bos - EU MDR Implementation: Light at the End of the Tunnel?
- 11:15 AM – 11:45 AM MST - Gert W. Bos - Solutions Circle: Writing the SSCP for Europe Is Child's Work...
- 2:00 PM – 3:00 PM MST - Mindy McCann - Safety and Performance Specifications - Challenges and solutions.
- 2:00 PM – 3:00 PM MST - Gert W. Bos - Recent Developments in EU Regulations (MDR and IVDR).
- 3:30 PM – 4:30 PM MST - Keith Morel - Postmarketing Clinical Follow-up (PMCF) & Risk Management.
Tuesday, Sept. 13, 2022
- 12:00 PM – 12:30 PM MST - Keith Morel - Solutions Circle: Types of Types and Types .. Er, Is That a Typo?
- 12:45 PM – 1:15 PM MST - Mindy McCann and Christie Hughes - Solutions Circle: Kits & Procedure Packs - Ranging from Easy to Impossible.
- 3:30 PM – 4:30 PM MST - Mindy McCann - Meaningful Conversations about Benefit Risk Analysis – A Panel Discussion.
- 4:35 PM – 5:30 PM MST - Mindy McCann - Beyond the MDR/IVDR: Medical Device Regulatory Compliance Challenges Outside of the MDR and IVDR.
- 4:35 PM – 5:30 PM MST - Gert W. Bos - EUDAMED & UDI – Evolution of the EU Regulatory Landscape.
- 4:35 PM – 5:30 PM MST - Keith Morel - How to Define the Expected Lifetime of a Medical Device & Its Consequences.
For more information about RAPS Convergence 2022, please visit the RAPS event website.