Originally Published EMDM May/June 2002
INDUSTRY NEWS
Complaint-Management Service LaunchedUS FDA's quality system regulation requires medical device manufacturers to review, evaluate, and, when appropriate, investigate complaints. Written procedures describing the process used to perform these activities must be maintained and a responsible individual or entity must be named to perform these tasks. To assist international device companies in meeting these requirements, Toltec International (Lakewood, CO, USA), an engineering firm that caters to regulated industries, has launched an FDA Complaint Processing service. The company made the announcement at Medical Design & Manufacturing West 2002 in Anaheim, CA, USA.
The service is especially useful to non-US device OEMs who may be unfamiliar with FDA reporting requirements. Toltec will take charge of analysis, record keeping, follow-up, and complaint-closure operations. Complaints are summarized and reported at periodic intervals. The company also issues trend reports, submits recommendations for corrective and preventive action, and implements agreed-to procedures.
For more information, contact Toltec International Inc., 938 Quail St., Ste. A, Lakewood, CO 80215, USA; phone: +1 303 2020148; fax: +1 303 2020152; e-mail: roy.hovland@toltecint.com; Internet: www.toltecint.com.
Copyright ©2002 European Medical Device Manufacturer
