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 several of country-specific regulatory authorities, each with their unique data exchange standards and requirements.
ViSU UDI takes a platform approach to help you overcome several drawbacks and short comings of solutions like GDSN, PLM/ERP based modules, and custom bespoke solutions. As countries requiring UDI increasing, you need a solution that’s flexible and adapts to continuous changes (both your internal data and external country requirements) without burdening internal resources and ensure keeping UDI compliance cost in control.
Our UDI solution enables 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, all done in cloud (or can implement on your servers).
Snapshot of our Solution with 2 major pieces – smartMaster, smartCommand