The Unique Device Identifier (UDI) helps medical-device manufacturers comply with the FDA Amendments Act of 2007 which mandates complete part traceability. The device scans, bar codes, and tracks each part and batch and saves all leak, functional, and lifecycle test data. The unit also gathers data for process optimization and stores data at each production stage for the statistical process control (SPC) method that is the base for most quality-assurance programs and full ISO 13485:2003 compliance. For added traceability, an optional laser marker can work with the bar-code labeler.
InterTech Development Co, 7401 N Linder Ave, Skokie, IL 60077, (847) 679-3377, intertechdevelopment.com