News
June 2, 2010
Medical Device Consultants, Inc. Completes Successful FDA Inspection
June 2, 2010, North Attleboro, MA - Medical Device Consultants, Inc. (MDCI), a full-service regulatory consulting firm and contract research organization (CRO) serving the medical device and diagnostics industry, underwent a routine surveillance inspection by the FDA, March 3 through March 16, 2010, at its corporate headquarters. MDCI's Quality System and clinical departmental SOPs were audited. In addition, FDA asked to review the study files for three active clinical trials. The Establishment Inspection Report (EIR) stated there were no significant concerns, no 483 was issued, and no response was required.
Leslie Rose, Director of Clinical Services, commented, "MDCI staff has demonstrated our commitment to adhering to the highest quality standards in the conduct of medical device clinical research. We are obviously pleased with the results of the FDA inspection. We work diligently to maintain high quality standards and are pleased to continue to demonstrate our efforts to sustain and continuously improve the quality of MDCI's services."
About MDCI
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 and California.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.