Guillaume Beaudry, M.Sc., is an expert in quality management and regulatory affairs, specializing in the field of medical devices and molecular diagnostics. He holds a Master’s degree in Physiology-Endocrinology and a Bachelor’s degree in Microbiology from Université Laval. He supports manufacturers in developing their regulatory strategies as well as in documenting product development and manufacturing activities, including risk analyses, testing protocols, and process validation.

With more than 20 years of experience in biotechnology research and development, Mr. Beaudry has led numerous complex projects within certified quality management systems (ISO 13485, ISO 15189, MDSAP, and 21 CFR Part 820), contributing to the approval of several innovative medical devices in Canada, the United States, and Europe.

Throughout his career, he has played a key role in the development of cutting-edge diagnostic platforms and tests, particularly in oncology and infectious diseases, as well as in the establishment and accreditation of specialized laboratories. He has also served for several years as a lead assessor and technical assessor for ISO 15189 and ISO 17025 standards.