April 25, 2024
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, Managing Director and VP, MedIcept, Inc.
Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific
Phil Pontikos, Investigator, Medical Device National Expert, Office of Regulatory Affairs/OO/OMPTO, Division of Medical Products and Tobacco Program Operations Branch, FDA (Invited)