Pablo Morales

Speaking Session: PMA: Welcome to the Big Leagues

Pablo Morales
Principal Consultant & Founder

Morales MedTech Advisors

Pablo Morales, MD, is a physician and regulatory strategist with over 16 years of leadership experience at the U.S. Food and Drug Administration (FDA). Across his regulatory career, Dr. Morales led the clinical review of more than 1,000 medical device submissions—including PMAs, 510(k)s, IDEs, De Novos, and breakthrough device designations.

At the FDA, he served as Chief Medical Officer in the Office of Clinical Evidence and Analysis within the Center for Devices and Radiological Health (CDRH). In this role, he provided clinical oversight across diverse therapeutic areas and contributed to key agency initiatives, including benefit-risk assessment frameworks, 510(k) modernization, and the rollout of the Early Feasibility Study (EFS) pathway. His expertise also encompasses clinical trial design, real-world evidence, bioethics, and post-market safety surveillance.

Dr. Morales completed his medical education at Universidad Pontificia Bolivariana in Colombia, followed by vascular surgery training at Guy’s and St. Thomas’ Hospital in London and an endovascular innovation research fellowship at the Cleveland Clinic. Through Morales MedTech Advisors, he advises medical device innovators on regulatory pathways, premarket submissions, and strategic FDA interactions to bring safe technologies to market.