WASHINGTON, Aug. 7, 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 […]
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MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter
WASHINGTON, Feb. 13, 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 […]
MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan
– MCRA’s acquisition of Vorpal Technologies K.K. (Vorpal) bolsters MCRA’s ability to support a domestic market within Asia, expanding MCRA’s overall geographical footprint allowing MCRA to be closer to its client base and their target markets. – Vorpal is the […]
MCRA Expands Neurology Division into Neurointerventional Market
– Robert Herrmann, Ph.D, Former U.S. Food & Drug Administration (FDA) Team Lead and Lead Reviewer for Neurointerventional and Neurosurgical Devices joins MCRA as Director, Neurointerventional Regulatory Affairs. WASHINGTON, Sept. 22, 2021 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory […]
MCRA Expands its Cardiovascular Division, Hiring Fernando Aguel, Former Assistant Division Director, FDA Circulatory Support Devices
WASHINGTON, May 20, 2021 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce the hiring of Fernando Aguel as […]
MCRA Hires Cardiovascular Industry Leader Dr. Hans-Peter Stoll to its CRO Management Team
– Dr. Hans-Peter Stoll is an interventional cardiologist and senior medical executive with 20 years of leadership experience who has demonstrated deep expertise in clinical strategy and execution. – Dr. Stoll supports and expands MCRA’s specialization in cardiology and clinical […]
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 […]
MCRA Assists CorFlow in Obtaining Breakthrough Device Designation
WASHINGTON, Dec. 3, 2019 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance, is pleased to announce its role in the successful granting of a Breakthrough Device […]
MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista
WASHINGTON, Nov. 19, 2019 /PRNewswire/ — MCRA, LLC is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance in a coordinated manner to assist companies in bringing new technologies and products to […]
MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs
WASHINGTON, March 5, 2019 /PRNewswire/ — MCRA, LLC, a leading medical device consulting firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance, is pleased to announce the expansion of its cardiovascular consulting activities through the […]