WASHINGTON, Feb. 2, 2023 /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 its work with Medtrade on obtaining the CE Mark for its CELOX™ PPH device. With MCRA’s assistance, Medtrade obtained approval for the device in early September 2022, advancing the timeline to market by over two years through a key shift in its strategy.
MCRA was retained by Medtrade to assist with reviewing the CE Marking strategy for the CELOX PPH device. CELOX PPH is designed to rapidly and effectively control uterine post-partum hemorrhage (PPH). MCRA’s European Regulatory Affairs team helped Medtrade develop an alternative, high payoff approach, focusing on qualitative improvements in clinical documentation and a strategy based on combining retrospective data with robust post-market data. The new indication was approved by the Notified Body, delivering the device to market significantly earlier than previously planned. CELOX PPH is now available on the market and helping to save lives.
Peter Bowness, Vice President of Regulatory Affairs & Operations – Europe, states “CELOX PPH is an amazing product. Bringing this device to market as quickly as possible represented a significant challenge; we at MCRA are honoured to have contributed to this achievement of providing life-saving treatment for post-partum haemorrhage, helping to safeguard the health of women and their families.”
Russ Mably, CEO of Medtrade Products Ltd, commented “We are extremely pleased with the guidance and input provided by Peter Bowness of MCRA in assisting us in bringing CELOX PPH CE certification much more quickly than expected into the European market. The CE certification represents an exciting milestone for Medtrade Products Ltd, as well as for mothers and clinicians who will benefit significantly from this highly effective innovation to control and treat PPH.”
MCRA is proud to continue supporting innovation in the medical device industry by helping clients navigate regulatory affairs in Europe, the United States, and Japan.
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 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
About Medtrade: Established in 1999, Medtrade is a UK based medical device company developing and bringing industry leading solutions to partners across the world. With offices in Crewe, UK and New York, US, the highly experienced leadership and specialist teams are committed to supporting business partners with market leading solutions in the Wound Care, Trauma and Hemostasis fields. Medtrade manages the entire product development process through to full product commercialisation. Integral to the success of Medtrade is the continued focus on innovation and a dedicated team are in place. New innovations aimed at addressing key global healthcare challenges such as biofilm, wound treatment, infection prevention, pressure injury prevention and control of bleeding are very much the focus. ISO 13485 certified, we have a successful legacy of providing market leading solutions to brand owners and our success is built upon an enviable track record of quickly and efficiently supporting brand owners with key or flagship products in support of their strategic marketing objectives. www.medtrade.co.uk
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: [email protected]
SOURCE MCRA, LLC
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