Visu UDI upgraded to Automate Regulatory Data Validation and Seamless EUDAMED Submissions
DDi launches Visu UDI for global UDI compliance-streamlining data validation, EUDAMED submissions, and master data management. With M2M connectivity and strict rules, it ensures accurate data across FDA, NMPA, and EU markets.
- (1888PressRelease) February 10, 2026 - To help medical device companies tackle the complexities of the EU’s Medical Device Regulation (MDR) and other global mandates, DDi, a leading provider of regulatory and clinical automation solutions, has launched Visu UDI, an advanced automation platform for global regulatory submissions.
Visu UDI distinguishes itself with a robust Machine-to-Machine (M2M) connectivity framework, eliminating the risks associated with manual file handling. The software features a sophisticated Regulatory Data Validation Engine that runs pre-submission logic to detect missing attributes and format errors before data ever reaches health authorities.
"With the shifting landscape of XML standards, manufacturers need more than a publishing tool - they need intelligent automation," stated DDi. "Our proprietary smartRules engine automatically picks up daily data changes, validates them against country-specific rules, and publishes the necessary files without manual intervention."
Technical Highlights:
• Global Gateways: Pre-configured connectors for FDA GUDID (HL7 SPL), China NMPA, and EUDAMED.
• System Agnostic Integration: Robust APIs ensure seamless connection with SAP, Oracle, Agile PLM, and major labeling software.
• Real-Time Tracking: Automated acknowledgment and error report handling (Ack & Nack management) provide total visibility into submission status.
For more information, visit https://www.ddismart.com/udi-unique-device-identification-solutions/
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