24 Nov MCRA Expands International Regulatory Team
Peter Bowness, Ph.D., former British Standard Institution (BSI) senior regulator and decision maker joins MCRA as Director, International Regulatory Affairs.
WASHINGTON, Nov. 23, 2021 /PRNewswire/ — MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) 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.
Dr. 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, 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.”
Dr. 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 MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and served nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
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