Unique Device Identification (UDI) is a major global harmonization effort for more consistent data that benefits overall product traceability throughout the medical device supply chain.
Markets are rolling out medical device UDI requirements, such as the USA FDA UDI (GUDID), EU MDR/IVDR UDI (EUDAMED), China NMPA UDI, and many more. Unfortunately, managing these independent systems with unique data sources from global markets has become problematic for all medical device manufacturers.
- Automated medical device UDI updates as product registrations change
- EUDAMED, GUDID and ROW Compliant
- Fully integrated into your existing PLM/ERP system