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Recent Press Releases

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.

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE.

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.

Key Facts

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Learn About Our Unique Approach to Your Challenges

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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