MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.
Global Regulatory
Our Global Regulatory Approach
In an ever shifting and expanding global regulatory climate, medtech markets are being driven by a more integrated regulatory, clinical, reimbursement, quality, compliance and cybersecurity approach. MCRA's expert regulatory consultants provide the knowledge and experience to support medical device and in vitro diagnostic device companies looking to gain access to established and emerging markets.
FDA Regulatory Consultant For Medical Devices
Our US Regulatory & FDA Experience
MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries. Our deep bench of FDA consultants in virtually every discipline creates value and mitigates risk by combining unparalleled comprehension of FDA laws and regulations. MCRA both advises and implements all types of strategies for all FDA submissions.
Global Clinical Research Organization (CRO)
Our Experience as a Dedicated CRO
We believe that MCRA's heritage of combining its integrated services in clinical trials has created a unique system including clinical research, regulatory, reimbursement, compliance and specialized therapy expertise.
The Impact of U.S. Regulation on Medical Device Innovation
Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.
The Impact of U.S. Regulation on Medical Device Innovation
Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.
MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA
WASHINGTON, April 24, 2018 /PRNewswire-USNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it delivered an informational presentation on April 16th about United States Medical Device Regulations to twenty-two members of the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA) in Beijing, China.
MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA
WASHINGTON, Jan.