MedCon 2025 has been announced!

April 23 - 25, 2025

Columbus, OH

AFDO RAPS Healthcare Products Collaborative
MedCon Conference

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2024 MedCon Agenda

April 25, 2024 @ 1:00 pm


2:00 pm

Incorporating PMS Risk Assessment / HHEs Into Quality and Regulatory Systems

Post Market Track

As seen by recent FDA Warning Letters and Notified Body Nonconformances, having a robust process linking post-market surveillance (PMS) data to Product Risk Assessments/HHEs is vital to meeting regulatory expectations. This session will explore sources of PMS information that could lead to potential field safety corrective actions. Discuss how to incorporate the Risk Management File into the escalation process(es), and also ensure utilization of the Risk Management Files (RMFs) within product risk assessment/HHE. Share industry experiences and the importance of RMFs for failure rate data requested by regulatory authorities.


Kim Trautman, Medical Device, IVD and Combo Product Expert

Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific


Katie Furtick, Principal Quality System Engineer, Boston Scientific

Kristen Hastings, Director of Design Quality, Haemonetics

Phil Pontikos, Investigator, Medical Device National Expert, Division of Medical Products and Tobacco Program, Operations Branch, Office of Regulatory Affairs (ORA), FDA

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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