Nov — 2019 MCRA Assists CorFlow in Obtaining Breakthrough Device Designation MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO read article
Nov — 2019 THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology read article
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 read article
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 read article
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 read article
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 read article
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. read article
Jan — 2018 MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA WASHINGTON, Jan. read article
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. read article
Dec — 2017 MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA NEW YORK, Dec. read article
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 read article
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 read article