Post Marketing Issues for Medical Devices: An Introduction
Learn how medical device manufacturers are required to evaluate and report post-market adverse events and product problems. Recognize when to conduct a recall and how corrections and removals are reported to the FDA. Understand how medical device manufacturers are required to monitor device performance following clearance or approval.
Véronique Li, Senior Medical Device Regulation Expert, Hyman Phelps & McNamara, PC
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2022.
VÉRONIQUE LI is a Senior Medical Device Regulation Expert at Hyman, Phelps & McNamara where she provides counsel to medical device and in vitro diagnostic (IVD) manufacturers with regard to both premarket and postmarket matters. In the premarket area, she assists clients with registration and listing activities and works with them on marketing applications (e.g., Emergency Use Authorizations (EUAs), IDEs, 510(k)s, de novos, and PMAs). She advises clients in preparation for pre- submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Véronique also conducts internal investigations to provide tailored recommendations to clients based on her findings. She also supports clients engaged in mergers and acquisitions. She conducts comprehensive FDA-related due diligence on the compliance and regulatory status of assets or targets and reviews supply, distribution, and manufacturing agreements. Prior to joining HPM, she worked at Abbott (formerly St. Jude Medical), PwC, and FDA. Ms. Li earned her BSE in Biomedical Engineering from Case Western Reserve University and her MBA from Boston University.Get Access
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