Unique Device Identification (UDI) is a key global harmonization process for more reliable data that aids overall medical device traceability throughout the device supply chain. Health Authorities rolled out medical device UDI requirements, such as GUDID by US FDA, EUDAMED by European Union under new MDR/IVDR, NMPA UDI by China, and many more.
Global device manufacturers must often submit UDI data to a myriad of country-specific regulatory authorities, each with their unique data exchange standards and requirements. Our UDI solutions enable device manufacturers to implement a single data syndication system for global coverage. Leveraging one solution to aggregate, validate and submit product data to regulatory agencies at the market-specific level around the globe.