The #1 Medical Device CRO with integrated regulatory, reimbursement, compliance, & quality.

MCRA

Learn About Our Integrated Services & Offerings

CRO Clinical Research

US Regulatory

International Regulatory

Reimbursement

Quality Assurance

Healthcare Compliance

Recent Press Releases

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

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

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

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.

Our Process

Our Process

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.

Key Facts

Corporate Overview

Executive Summary and Key Facts

Download Overview

Learn About Our Unique Approach to Your Challenges

MCRA combines world class know-how and execution in combination with providing your team with a hands-on, proactive, and team-based support at every step of your technology's life cycle.

© MCRA 2019

All Rights Reserved | Terms of Use