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
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 read article
Jul — 2017 MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy Mr. read article