The #1 Medical Device CRO with integrated regulatory, reimbursement, compliance, & quality.

MCRA

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Recent Press Releases

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years - 15 Month PMA Approval Process (Versus 30 Month Average of Ortho/Spine Over Past 10 Years)

WASHINGTON, March 7, 2019 /PRNewswire/ -- MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by th

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 integra

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process.

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

WASHINGTON, Jan.

Our Process

Our Process

MCRA's integrated approach creates value and mitigates risk throughout the technology innovation lifecycle.

MCRA works through the entire research and development (R&D) lifecycle through commercialization.

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MCRA combines world class know-how and execution in combination with providing your team with a hands-on, proactive, and team-based support at every step of your technology's life cycle.

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