Véronique Li

Speaking Session: FDA Said No. Now What?

Véronique Li
Senior Manager

Exponent

Véronique Li, MBA, is a Senior Manager in Exponent’s Biomedical Engineering & Sciences practice in Philadelphia, bringing over 15 years of experience in medical device regulation, FDA compliance, and healthcare commercialization strategy. A former Food and Drug Administration (FDA) regulator, Ms. Li previously served as a lead reviewer and policy advisor within both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

Throughout her career, Ms. Li has led more than 200 regulatory consulting projects, advising manufacturers, law firms, and private equity investors on premarket submissions—including 510(k)s, PMAs, De Novos, and IDEs—as well as quality management systems and due diligence. Prior to joining Exponent, she served as a senior medical device regulatory expert at Hyman, Phelps & McNamara, where she guided executive teams and conducted regulatory due diligence for over 85 mergers and acquisitions. Her background also includes healthcare consulting at PricewaterhouseCoopers and technical service at Abbott Laboratories.

A recognized industry thought leader with over 50 published analyses and frequent speaking engagements, Ms. Li holds an MBA from Boston University and a BSE in biomedical engineering from Case Western Reserve University.