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MCRA, a medical device and biologics advisory firm and clinical research organization integrating U.S. and international regulatory, clinical research, reimbursement, healthcare compliance, quality assurance and cybersecurity is pleased to announce Peter Bowness, Ph.D., former British Standard Institution/BSI senior regulator and decision maker joins MCRA as Director, International Regulatory Affairs.
Dr. Bowness has 9+ years of experience at BSI in regulatory compliance and operational delivery of conformity assessments and certification for surgical implants, surgical instruments, devices introducing substances to the body, IVF/ART instruments and media and devices utilizing materials of human/animal/biological origin. Dr. Bowness has extensive knowledge of EU regulatory processes under Regulation (EU) 722/2012 for EU CE and UKCA, and conducted the conformity assessment for the world’s first MDR certificate.
Before joining BSI, Dr. Bowness was R&D Project Lead for the biologics platform at Covidien (now Medtronic) specializing in the development of collagen based implantable medical device systems.
MCRA’s Vice President, Global Regulatory Affairs, Michelle McDonough said, “The addition of Dr. Bowness to the MCRA International Regulatory team expands our European footprint and introduces an added level of subject matter expertise related to European regulations. The added insight into the inner workings and mindset at Notified Bodies, in addition to his extensive knowledge in medical device materials and related challenges, complements the existing team extremely well, and is only going to increase the value-add to our regulatory and CRO clients.”
Source: MCRA, LLC
