Unique Device Identification (UDI) Solutions - Clinical, Regulatory & Automation solutions for Life Sciences

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.

Validation

Deliver trusted, high-quality product data by leveraging our standard data quality and data validation tools. Ensure that product data is accurate and compliant with any pre-defined set of validation rules from regulatory agencies, as well as any internal, user-configured data attributes and validation rules.

Electronic Submissions / Gateway

Proven electronic submission capabilities for regulatory data submissions that ensure data accuracy and a scalable process for data compliance in all markets. Ease of enabling new countries at a fraction of the cost of alternatives such as data submission services or standalone country-level compliance solutions

UDI Partner Interfaces

Pre-configured connectors to all major GDSN-compliant data pools including 1WorldSync, GHX, NPC, and Syndigo that enable global data synchronization with recipient-specific product attributes Out-of-the-box connectors to UDI databases across the globe including FDA’s GUDID, Europe’s EUDAMED and China’s UDID

Data Pooling & Mapping

‘Drag & drop’ functionality helps data analysts map, extract and collate master data to any target data recipient, be it a system or a process. All major file & message formats are supported ‘out-of-the-box’. Data collation can be automated using scheduled jobs, or custom interfaces or real-time web services APIs

System Integration

Easily integrate to RIM, PLM, ERP and other systems to source the relevant master data using configurable message/file formats. Supports AS2 gateways and AS4 Access Points for message delivery using all required XML formats including the GS1 XML for GDSN, HL7 SPL for GUDID, and SOAP XML for EUDAMED.

DDi can put you on the fast track to Device Unique Device Identification (UDI) Solutions