MCRA11.30.21
MCRA LLC, a medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO), has appointed Peter Bowness, Ph.D., former British Standard Institution (BSI) senior regulator and decision maker, as director, International Regulatory Affairs.
Bowness currently serves as chair of the British Standards Institution technical committee CH/210/WG3 and Member ISO/TC/210 (Quality management and corresponding general aspects for medical devices), Member CH/210/04 (Risk analysis for Medical Devices) and Member CH/194 (Biological Evaluation of Medical Devices).
Before joining BSI, 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."
Bowness said: "The seismic shift in European regulations triggered by MDR, IVDR, Brexit and the end of the Swiss MRA represents a unique and significant challenge to the medical device industry in Europe. I am excited to join MCRA, providing Notified Body regulatory expertise to guide manufacturers in navigating this evolving landscape."
About Dr. Bowness
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. 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.Bowness currently serves as chair of the British Standards Institution technical committee CH/210/WG3 and Member ISO/TC/210 (Quality management and corresponding general aspects for medical devices), Member CH/210/04 (Risk analysis for Medical Devices) and Member CH/194 (Biological Evaluation of Medical Devices).
Before joining BSI, 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."
Bowness said: "The seismic shift in European regulations triggered by MDR, IVDR, Brexit and the end of the Swiss MRA represents a unique and significant challenge to the medical device industry in Europe. I am excited to join MCRA, providing Notified Body regulatory expertise to guide manufacturers in navigating this evolving landscape."