Unique Device Identifier System for Medical Device Manufacturers

Medical device manufacturers seeking to comply  with the FDA Amendments Act of 2007 and to enhance patient safety with complete part traceability, can now use the InterTech Development Unique Device Identifier (UDI) System, which integrates bar coding, scan and software tracking of each part and batch, including all leak test, functional test and lifecycle test data related to each component .

 The InterTech Development UDI System not only provides full traceability in the event of product recalls, but also provides data for process optimization to streamline production, and storage of all test data at each productions stage for SPC (Statistical Process Control) data that underlies most quality assurance systems and full ISO 13485:2003 compliance.

For added traceability, a laser marking system can be integrated with the bar code label system.

Jacques Hoffmann, president of InterTech Development Company, comments, “InterTech’s turnkey test solutions have always emphasized software integration to monitor all stages of testing and archive all test data.  Above and beyond the UDI system finalized by the FDA for minimum parts traceability requirements, the InterTech UDI system will enable device manufacturers to glean from constantly archiving test data the process improvements they need to make to improve yield, minimize defects, and ensuring that products jeopardizing patient safety are never released to market.”