Background
Dave McGurl is a seasoned regulatory expert specializing in U.S. medical device regulations. With extensive experience leading regulatory projects, he has authored numerous regulatory submissions, including 510(k)s, PMAs, De Novos, IDEs, and HDEs. Dave excels in regulatory strategy formulation, submission development, clinical protocol design, and compliance reviews.
Education
Dave McGurl earned his Bachelor of Science in Bioengineering with a concentration on biomechanics from the University of Pittsburgh. This educational background provides him with a comprehensive understanding of medical device technologies and regulatory processes, enabling him to offer strategic regulatory guidance to clients.
Experience
Mr. McGurl began his regulatory career in 2009 at the FDA, dedicating seven years to orthopedic devices, holding pivotal roles such as acting branch chief and senior lead reviewer of the orthopedics branch. Since joining MCRA, he has guided hundreds of clients through the intricate FDA regulatory process.
Overview
Mr. McGurl's work at MCRA focuses primarily on U.S. medical devices, specializing in orthopedic joint arthroplasty, trauma, sports medicine, navigation, robotics, wound management, and plastic and reconstructive devices.