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Ms. Li brings 15+ years of experience in medical device compliance and commercialization to Ä¢¹½tv's Biomedical Engineering & Sciences practice in Philadelphia 

Ä¢¹½tv is pleased to welcome Véronique Li, MBA, as a senior manager in our Biomedical Engineering & Sciences practice in Philadelphia. A former Food and Drug Administration regulator, Ms. Li has more than 15 years of experience in FDA compliance, medical device regulation, and healthcare strategy, bringing a unique perspective on medical device development and regulation to Ä¢¹½tv. 

During her career, Ms. Li has specialized in product development, regulatory pathways and submission processes, interpretation of FDA policies and guidance documents, due diligence, and quality management, primarily within the medical device industry. She has led more than 200 regulatory consulting projects involving premarket 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.

Before joining Ä¢¹½tv, 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 for more than 85 mergers and acquisitions. Her extensive background includes key roles at FDA's Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), where she served as a lead reviewer and policy advisor. Earlier in her career, she held positions as a healthcare consultant with PricewaterhouseCoopers and as a certified technical service specialist with Abbott Laboratories (formerly St. Jude Medical). She holds an MBA from Boston University and a BSE in biomedical engineering from Case Western Reserve University.

Ms. Li is widely recognized as a thought leader in FDA regulatory affairs, with more than 50 published analyses addressing policy developments, guidance documents, enforcement actions, and regulatory trends. Her work has appeared in leading industry outlets including FDLI Update Magazine and The FDA Law Blog, and she has co-authored articles and contributed to professional publications from the Regulatory Affairs Professionals Society (RAPS) and the American Bar Association. She is a frequent speaker and instructor for FDLI training courses, sharing expertise on investigational device exemptions, clinical investigations, and postmarket compliance, and she has served as adjunct faculty at George Washington University.

I specialize in helping organizations navigate complex FDA requirements related to compliance and commercialization. I am excited to leverage the multidisciplinary teams at Ä¢¹½tv to deliver services and support aligned with regulatory requirements and business objectives.

— Véronique Li, MBA, Senior Manager, Biomedical Engineering and Sciences

At Ä¢¹½tv, Ms. Li brings a consulting approach that integrates regulatory intelligence monitoring, gap analysis, risk assessment, and cross-functional stakeholder engagement, delivering actionable recommendations to support compliance and innovation. She is certified in quality management systems and Six Sigma Green Belt methodology, with expertise spanning ISO 13485, 21 CFR Part 820 (Quality System Regulation), CAPA systems, complaint handling, and data integrity assessments.

About Ä¢¹½tv's Biomedical Engineering & Sciences practice

Ä¢¹½tv's multidisciplinary Biomedical Engineering & Sciences teams deliver evidence-based insights for clients across medical specialties and therapeutic sectors, supporting the safety, performance, and regulatory compliance of biologics, biomaterials, diagnostics, implants, combination products, and many other medical devices. Ä¢¹½tv's state-of-the-art laboratories and computational modeling capabilities enable our experts to perform advanced preclinical testing and evaluations, numerical modeling, and failure analysis, generating meaningful data for use in regulatory submissions and throughout the total product lifecycle.