Melissa Hall

Speaking Session: The 510(k) Was Never the Problem: Why bad regulatory strategy starts long before the submission.

Melissa Hall
Founder and Principal Consultant

Statera Regulatory Consulting, LLC

Melissa Hall is a seasoned regulatory affairs professional with over 13 years of experience specializing in U.S. Food and Drug Administration (FDA) regulation of medical devices. A former FDA reviewer, manager, policy analyst, and industry educator, she brings a deep, insider understanding of FDA expectations, regulatory pathways, and review dynamics.

In her current role as a regulatory consultant and strategic advisor, Melissa supports medical device companies in developing and executing effective regulatory strategies, preparing high-quality submissions, and engaging in clear, productive communication with the FDA. She is particularly valued for her ability to translate complex regulatory requirements into practical, risk-based solutions that facilitate efficient review and market access. Melissa is an active member of the Regulatory Affairs Professionals Society (RAPS) and a frequent speaker at industry conferences, reflecting her ongoing commitment to regulatory education and professional development. She also serves as a regulatory advisor to multiple MedTech startups participating in accelerator and innovation programs. Her experience spans a broad range of device areas, including cardiovascular, orthopedic, spine, ENT, feminine care, ophthalmology, dental, and medical imaging technologies.