Tag: MCRA

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

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 […]

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 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 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 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 […]