News
June 5, 2009
Medical Device Consultants, Inc. Certified to New ISO 9001:2008 Standard
June 5, 2009 – North Attleboro, MA - Following a systems audit at its corporate headquarters, Medical Device Consultants, Inc., (MDCI) has been certified as conforming to the new Quality Management System Standard ISO 9001:2008.
MDCI, a full-service regulatory consulting firm and contract research organization (CRO), was certified in the "provision of consulting services in the clinical, regulatory, quality assurance, and associated business areas for the medical device, in vitro diagnostic and biotechnology industries."
MDCI works with emerging and established companies worldwide to deliver customized strategic guidance and creative “hands-on” solutions to address unique FDA, EU, and international regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
The certification was issued June 2, 2009 by BSI Management Systems following the completion of an on-site audit. MDCI has been certified to ISO 9001 Standards continuously since the initial certification was earned in October 1998.
Founded in 1980, MDCI has helped hundreds of clients conduct successful medical device and IVD clinical trials, achieve regulatory clearance and approval, and maintain compliance for innovative and cutting-edge medical products and technology in the U.S., Europe, Canada, and internationally. By leveraging MDCI’s comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace. MDCI has offices in Massachusetts, California, and London.
For more information on MDCI’s ISO 9001:2008 certification, or additional details about MDCI’s full range of services to support medical device and in vitro diagnostic clients, email info@mdci.com or visit www.mdci.com.
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