With over 10 years of experience in orthopedics, medical devices, and regulatory affairs, Dave McGurl is a Director of Regulatory Affairs at MCRA. Mr. McGurl is a seasoned regulatory expert with proficiency in U.S. and international medical device regulations. Mr. McGurl specializes in regulatory strategy, writing of regulatory submissions, clinical protocol design and development, analysis of pre-clinical and clinical data, and regulatory compliance review of marketing/labeling materials for medical devices.
Mr. McGurl received his Bachelor of Science from the University of Pittsburgh in Bioengineering with a concentration on biomechanics.
Prior to joining MCRA in March 2016, Mr. McGurl worked for 7 years at the FDA in the premarket orthopedic devices branch. During his time at FDA, Mr. McGurl held several positions including acting branch chief of the orthopedics branch and senior premarket lead reviewer. Throughout his professional career, Mr. McGurl has reviewed or written hundreds of regulatory submissions including 510(k)s PMAs, De Novos, IDEs, HDEs, CERs, STEDs, Technical Files, and Design Dossiers.
Overview
Mr. McGurl's work at MCRA focuses primarily on both international and U.S. medical devices with a specialization in orthopedic arthroplasty, trauma, and sports medicine.