COVID-19Regulatory

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

WASHINGTON, March 24, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality systems as a result of the COVID-19 pandemic. MCRA’s toll free coronavirus hotline can be contacted by phone at 877-796-8411 or by email at info@mcra.com.

MCRA is committed to the health and safety of individuals and to the industry as a whole and is offering guidance and services to help companies efficiently navigate the regulatory process to bring technologies to market in the U.S. to aid in the diagnosis, monitoring, and prevention of COVID-19.  MCRA is in discussions with multiple companies seeking to pursue the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA) regulatory pathway for devices or diagnostics for COVID-19.  This unique regulatory mechanism was developed to permit access to unapproved medical products or unapproved uses of approved medical products during times of emergency when there are no adequate or approved alternatives available. 

Products MCRA is supporting include, but are not limited to, personal protective equipment, test kits for clinic and at home uses, ventilators, cardiopulmonary monitoring systems, and respiratory treatment devices.

MCRA’s COVID-19 taskforce is keeping up to date with new information and guidance documents released by FDA.  Glenn Stiegman, MCRA’s Senior Vice President of Clinical & Regulatory Affairs, said, “MCRA remains in constant contact with FDA and other constituents to stay on top of and implement necessary actions to help our clients, partners, and colleagues during the coronavirus crisis. We welcome the opportunity to provide support as it relates to COVID-19’s impact on decisions regarding changes to study conduct or regulatory strategies and whether documentation should be submitted to FDA.”

About MCRA, LLC: 

Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA’s value contribution rests within its industry experience at integrating five business value creators—regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics, in vitro diagnostic (IVD) devices, personal protective equipment, test kits for clinic and at home uses, ventilators, cardiopulmonary monitoring systems, and respiratory treatment devices.

Contact
Toll free hotline: 877-796-8411 (Monitored Monday-Friday between 8:30am and 5:30pm US EST)
Email address: info@mcra.com

SOURCE MCRA, LCC

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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