Press Releases

Aug — 2020

MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director

WASHINGTON, Aug.

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Mar — 2020

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

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Jan — 2020

MCRA Strengthens Its Reimbursement, Health Economics, and Market Access Division with the Hiring of John D. McDermott, Jr., MBA

WASHINGTON, Jan.

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Nov — 2019

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO

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Nov — 2019

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

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Nov — 2019

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

WASHINGTON DC, November 19, 2019 /PRNewswire/ -- MCRA, LLC, is a leading medical device advisory firm and clinical research organization (CRO) that

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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

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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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Expand Your Healthcare Distribution With MCRA Global Access

A unique integrated perspective for creating the optimal product pathway

Deep Therapy Experience

Expand Your Healthcare Distribution With MCRA Global Access

Press Releases

MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

MCRA Strengthens Its Reimbursement, Health Economics, and Market Access Division with the Hiring of John D. McDermott, Jr., MBA

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

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