Veronique Li Senior Medical Device Regulation Expert 202-737-7552
Veronique Li

Overview

Véronique Li is a Senior Medical Device Regulation Expert at HPM. She provides counsel to medical device and in vitro diagnostic (IVD) manufacturers with regard to both premarket and postmarket issues. In the premarket area, she prepares Emergency Use Authorizations (EUAs), IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and representing clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. She has provided FDA perspective in M&A transactions and has worked with attorneys to conduct comprehensive FDA-related due diligence and to advise clients on making determinations concerning deals and their valuations. Véronique also has experience conducting internal investigations.

Prior to joining HPM, she served as a field engineer at Abbott (formerly St. Jude Medical), a healthcare management consultant at PwC, and as lead reviewer and policy advisor at the FDA in both the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

Véronique earned a B.S.E. in biomedical engineering from Case Western Reserve University and an M.B.A. in healthcare management from Boston University.

Education & Admissions

Education

M.B.A., Health Sector Management, Boston University
B.S.E., Biomedical Engineering, Case Western Reserve University

Experience

Medical Devices

  • Prepares and reviews product submissions, including, 510(k)s, IDEs, and Pre-Submissions.
  • Counsels clients in responding to FDA deficiency letters and requests for additional information.
  • Evaluates and develops regulatory and marketing strategies.
  • Assists with determining regulatory requirements for product modifications, including design, supplier, and manufacturing changes.
  • Advises on MDRs and complaint handling, recalls, corrections, and removals.
  • Advises on enforcement actions, including, 483s and warning letters.
  • Prepares regulatory procedures (e.g., complaint handling, MDR, recalls).
  • Reviews promotional material and labeling.
  • Performs regulatory due diligence for mergers and acquisitions.
  • Assists companies with Quality System Regulation (QSR) matters.

In Vitro Diagnostic Devices

  • Helps clients develop regulatory strategies for clearance and approval.
  • Provides guidance on Laboratory Developed Tests (LDTs).
  • Provides advice on requirements for RUO assays and instruments.
  • Assists with post-market compliance.

Corporate Policies and Compliance Matters

  • Prepares and advises on corporate policies and compliance matters.
  • Drafts and reviews contracts related to various regulated matters (e.g., distributor agreements, supplier agreements).