Medical Device Consultants, Inc. (MDCI®) is a full-service regulatory consulting firm helping medical device, diagnostic and biotechnology manufacturers bring products to market faster and maintain compliance.

MDCI® provides regulatory assistance and support, including strategic planning, preparation and review of U.S. FDA submissions (IDE, 510(k), PMA), CE marking preparation, design dossier and technical file preparation, and Canadian License Applications. MDCI® can also serve as U. S. Agent for clients outside of the U.S.

MDCI® also provides an full range of clinical study/trial services, including multi-national clinical study design, management, and monitoring.

Finally, MDCI® can design, assess, and implement quality systems to meet U.S. FDA QSR, ISO, European and Canadian regulations.

Contact Information

49 Plain Street
North Attleboro
MA 02760
USA