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Medical Device Consultants, Inc.
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
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