Company: Medical Device Services Inc.
Date: 12/13/2001
Product Name: Single use medical devices, such as general surgery, orthopedic, laparoscopic and cardiovascular instruments, including biopsy forceps, needles, burrs, drill bits, saw blades, trocars, retractors, blood pressure cuffs, catheters and guidewires
Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example:
The associated computer hardware and software used to identity incoming devices.
Software used to control the production and assignment of work orders and the control of master SOPs.
The software and hardware used to print labeling.
FDA District: Denver District Office
