Veronique Li

Véronique Li is a Senior Medical Device Regulation Expert at HPM, where she helps medical device and in vitro diagnostic (IVD) manufacturers navigate complex FDA regulatory requirements across the full product lifecycle.

She advises clients on both premarket and postmarket matters, including preparing and submitting Emergency Use Authorizations (EUAs), Investigational Device Exemptions (IDEs), 510(k)s, De Novo requests, and Premarket Approval (PMA) applications. Véronique also assists clients with pre-submission strategies and represents them in meetings with FDA. On the postmarket side, she counsels clients on complaint handling, Medical Device Reporting (MDR), field actions, and Quality System Regulation (QSR) compliance.

Véronique’s regulatory insight also extends to M&A transactions, where she provides FDA-related due diligence and helps clients assess potential risks and valuations. She has experience conducting internal investigations and advising on FDA compliance considerations in corporate contexts.

Before joining HPM, Véronique held roles as a field engineer at Abbott (formerly St. Jude Medical), a healthcare management consultant at PwC, and as a lead reviewer and policy advisor at FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).

She earned her B.S.E. in Biomedical Engineering from Case Western Reserve University and an M.B.A. in Healthcare Management from Boston University.