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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
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.
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.