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 are rolling 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. As per the new UDI requirements, managing these autonomous systems with unique data sources (Unstructured data and unauthorized sources) from international markets has become challenging for all medical device manufacturers.
Why Unique Device Identification (UDI) Solutions Matters?
Integrate to Labeling Sources
ViSU sources label regulatory data directly from our products registration module or your labeling software or enterprise business application and incorporate business rules for efficient, precise UDI labeling automation.
Meet UDI Requirements compliance, with less pain & cost
DDi’s solution enables you to rapidly respond to changes in regional and international regulations for labeling mandated by the Global UDI Systems. As you register products, UDI information is automatically updated, such as EU member states or country-level expiry dates, notified bodies, and device classifications.
UDI labeling compliance is never one and done. After compliance has been achieved for the first time, regulatory data must be updated in the cloud as triggers are realized. With ViSU Medical Device manufacturers address UDI regulatory compliance for different countries, In addition, while capitalizing on the benefits of streamlining operations by UDI, manufacturers can also improve patient safety and traceability
DDi can put you on the fast track to Device Unique Device Identification (UDI) Solutions
The First Step
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