Academic Credentials
  • M.B.A., Health Sector Management, Boston University, 2011
  • B.S.E., Biomedical Engineering, Case Western Reserve University, 2006
Academic Appointments
  • Adjunct Professor, The George Washington University, Washington, DC, 2019–2023

Véronique Li, MBA, is a Senior Manager at Exponent with more than 15 years of experience in FDA compliance, medical device regulation, and healthcare strategy. She specializes in product development, regulatory pathways and submissions, interpretation of FDA policies and guidance, due diligence, and quality management mostly across the medical device industry.

Ms. Li has led more than 200 regulatory consulting projects involving pre-market submissions (e.g., 513(g)s, RFD(s), breakthrough designations, EUAs, Q-Submissions, IDEs, De Novos, 510(k)s, PMAs), due diligence assessments, compliance audits, and quality system evaluations, providing expert analysis and strategic guidance for medical device manufacturers, consulting firms, law firms, and private equity firms. Her work encompasses regulatory intelligence, post-market surveillance, labeling and promotional review, and FDA enforcement responses, with particular expertise in medical device clinical investigations and Quality Management System (QMS) compliance.

 She has served clients by helping them address challenges related to FDA Form 483 and Warning Letter responses, regulatory pathway selection for novel technologies, Medical Device Reporting (MDR) and recall management, and mergers and acquisitions due diligence. Her consulting experience spans pre-submission strategy, investigational device exemption (IDE) submissions, 510(k) preparation, post-market compliance (e.g., registration and listing, UDI compliance), and corporate policy development for FDA-regulated products. Additionally, she has advised on Small Business Designations and drafted allegations of regulatory misconduct. Her experience expands across a wide range of medical products, including cardiac electrophysiology, combination products, dental, digital health, ENT, gastrointestinal, general surgery, general wellness, in vitro diagnostic, neurological, ObGyn, ophthalmic, pediatric, renal, respiratory, and transplant devices.

 Ms. Li's consulting approach integrates regulatory intelligence monitoring, gap analysis, risk assessment, and cross-functional stakeholder engagement to deliver actionable, compliance-focused recommendations. She is certified in Quality Management Systems and Six Sigma Green Belt methodologies. Her expertise includes ISO 13485, Part 820 (Quality System Regulation), corrective and preventive actions (CAPAs), complaint handling systems, and data integrity assessment.

 Before joining Exponent, Ms. Li served as a senior medical device regulatory expert at Hyman, Phelps & McNamara, where she advised senior executives on regulatory strategy and conducted due diligence on over 85 mergers and acquisitions. She previously worked at the FDA's Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), where she served as Lead Reviewer and Policy Advisor. Earlier in her career, she was a healthcare consultant at PricewaterhouseCoopers and a Certified Technical Service Specialist at Abbott Laboratories (formerly St. Jude Medical). She earned her MBA from Boston University and her BSE in Biomedical Engineering from Case Western Reserve University.

 Ms. Li is a recognized thought leader in FDA regulatory affairs, having authored more than 50 publications analyzing FDA policies, guidance documents, enforcement actions, and regulatory trends for industry publications including the Food and Drug Law Institute (FDLI) Update Magazine and The FDA Law Blog. She co-authored a RAPS article with former FDA colleagues to provide guidance on career considerations and options after FDA. She regularly presents at FDLI training courses on investigational device exemptions, clinical investigations, and post-market compliance. She has contributed to a chapter to an American Bar Association publication on FDA regulation of digital health products and has served as adjunct faculty at The George Washington University.