Our Team

Melissa is a seasoned medical device regulatory expert with over 11 years of experience specializing in Food and Drug Adminstration (FDA) regulations for medical devices. As a former-FDA reviewer, manager, industry educator, and policy analyst, she has a deep understanding of the Agency’s position and regulatory pathways. In her current role as a regulatory consultant and advisor, she assists companies in preparing effective regulatory submissions and offers strategic communication with the FDA. Continuing her passion for industry education, Melissa is an active RAPS member who has spoken at various RAPS conferences, including most recently, RAPS Convergence 2024 about effectively utilizing eSTAR. She also serves as a regulatory advisor to various MedTech start-up companies in the Larta accelerator program. She has experience assisting clients in the cardiovascular, orthopedic, spine, ENT, ophthalmology, dental, and imaging medical device spaces.