Press Releases

Apr — 2019

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

WASHINGTON, April 4, 2019 /PRNewswire/ -- MCRA, LLC has announced its role in the successful granting of the first De Novo for a device in

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Mar — 2019

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

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

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Mar — 2019

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

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Feb — 2018

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.

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Jan — 2018

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

WASHINGTON, Jan.

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Jan — 2018

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.

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Dec — 2017

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

NEW YORK, Dec.

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Nov — 2017

MCRA Leads Innovation Training with FDA as Part of its Experiential Learning Program (ELP)

The Experiential Learning Program (ELP) is a learning opportunity designed to help all levels of FDA within the Center for Devices and Radiological

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Sep — 2017

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

The Experiential Learning Program (ELP) is a program designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH

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Jul — 2017

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

As the medical device market grows due to continued innovation and changing demographics, it is imperative for industry to be able to successfully

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Jul — 2017

MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

Mr.

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Feb — 2017

MCRA Expands, Moves to New DC Location

WASHINGTON, Feb.

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Press Releases

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs

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

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

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

MCRA Leads Innovation Training with FDA as Part of its Experiential Learning Program (ELP)

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

MCRA Expands, Moves to New DC Location

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