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.