WASHINGTON, Oct. 31, 2022 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance and Japan Distribution Logistics (DMAH) support is pleased to announce the expansion of its European Regulatory Affairs division with the hiring of Dr. Erica Conway as its Vice President of In-Vitro Diagnostics (IVD) Regulatory Affairs, Europe.
Dr. Conway joins MCRA from the British Standard Institution (BSI), where she spent over eight years in major roles as the Global Head of IVD and latterly the Head of IVD Notified Body (NB). At BSI, Dr. Conway was pivotal in the implementation of the IVD Regulation (IVDR) and the successful designations of both the UK and the Netherlands organizations to the IVDR. Dr. Conway also regularly worked with government and European stakeholders regarding IVD procedures and guidelines. Prior to her time at BSI, Dr. Conway worked in various regulatory affairs roles, for both IVD manufacturers and as an independent consultant. These positions have culminated in over 20 years of regulatory affairs experience, which she now brings to this leadership role at MCRA.
At MCRA, Dr. Conway will lead the European IVD team under the Regulatory Affairs Division. Dr. Conway is responsible for MCRA’s European services for IVDs and will lead a team in supporting manufacturers with their transition, and CE-marking, to the new European framework. These consultations include regulatory strategy, design, and review of clinical performance study plans, as well as working interactively with clients to overcome regulatory questions and issues in Europe. Dr. Conway and her team will collaborate with all stakeholders, including Notified Bodies, to provide strategic feedback and expertise to MCRA regulatory clients to enable successful outcomes.
David Lown, MCRA’s President said, “With MCRA’s expansion in Europe, it is imperative we bring in leaders that understand this unique regulatory landscape to aid our clients. Erica Conway is a recognized leader in the IVD space in Europe and has played a critical role in implementing the IVDR at BSI. As Erica joins MCRA, our clients now have a renowned expert in the IVD field to provide expert feedback as they go through their IVD medical device submission cycle. We at MCRA are proud to have Erica Conway join as the Vice President of IVD Regulatory Affairs, Europe.”
Peter Bowness, Vice President, Regulatory Affairs & Operations – Europe said, “The medical device industry in Europe has gone through significant change in recent years. Having led two successful IVDR designations, Erica brings a unique understanding of the IVDR, including behind the scenes insight into the European system, to MCRA; representing an unparalleled level of expertise for manufacturers working in the European IVD market.”
Dr. Conway said, “I am excited to be joining MCRA at such a pivotal time in the European regulatory sector. My work at BSI, particularly at such a critical period with the publication and implementation of the IVDR, and my previous years in the industry, has afforded me the understanding of the complexities and solutions that are now needed in order to seek successful outcomes for manufacturers, to enable IVDs to be CE-marked to this new legislation, and to take a global approach to their development strategy. I look forward to using my experience to lead the IVD Regulatory Affairs team at MCRA.”
MCRA is proud to continue supporting innovation in the medical device industry by helping clients navigate the IVD landscape at a global level.
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics 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, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, 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 specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: [email protected]
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SOURCE MCRA, LLC