Medical device packagers can make use of a system to help with regulatory compliance and enhance patient safety.
The InterTech Development Unique Device Identifier (UDI) System offers complete part traceability. It integrates barcoding, scan and software tracking of each part and batch, including leak test, functional test and life cycle test data related to each component.
UDI is said to be a valuable tool in the event of product recalls, provides data for improving processes to streamline production, and stores test data needed in quality assurance systems and full ISO 13485:2003 compliance.
For added traceability, a laser marking system can be integrated with the barcode label system.
Device manufacturers can improve yield, minimise defects, and ensure that products jeopardising patient safety are never released to market, says Jacques Hoffmann, president of InterTech Development Company.
