Regulatory

MCRA Announces European Expansion

WASHINGTON, Jan. 10, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its expansion in Europe with three new offices in London, United Kingdom, Winterthur, Switzerland, and Eschborn, Germany.

In addition to these new offices, MCRA has also expanded its service offerings in Europe to accommodate growing client needs. MCRA Europe now offers GDPR compliance, representative services for clinical studies and Unique Device Identifier (UDI) services in addition to its core services of Regulatory Affairs, Clinical Research and Quality Assurance.

Peter Bowness, Vice President, Regulatory Affairs & Operations – Europe, states, “With the shifts in regulations between the UK and Europe, it is a critical time across Europe for the MedTech industry. Having a strong consulting firm such as MCRA to guide clients through the Notified Body process reduces time, cost, and risk, optimizing time to market.”

Abigail Allen, Vice President, Clinical Affairs states, “Our European presence further supports our global CRO by facilitating access to European patients and utilizing our country specific knowledge and expertise to streamline approvals and trial management. Expanding MCRA’s European footprint is designed to integrate clinical research and regulatory approvals globally. We are proud to open new offices and offer expanded services to clients across Europe to better meet the growing needs globally.”

Anthony Viscogliosi, CEO of MCRA, states “Europe is the second largest medical device market in the world. With a marked increase in the MedTech sector in Europe over the past decade, MCRA anticipated our clients’ needs and worked diligently to provide more services and resources to meet client and patient needs in Europe.”

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 client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity, 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, the United Kingdom, Winterthur, Switzerland, Eschborn, Germany 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, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. 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: ahoward@mcra.com

SOURCE MCRA, LLC

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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