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Visu UDI upgraded to Automate Regulatory Data Validation and Seamless EUDAMED Submissions

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.”

VisuUDI-by-DDi

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/

About DDi

DDi, a Makro Group company, is a Life Sciences-focused software products and solutions provider. Headquartered in New Jersey, USA, with offices in the UK, India, and Singapore, we deliver smarter technology and AI-driven solutions for enterprise-level Clinical Development, Regulatory, and Safety domains. Our innovative technology products and automation solutions cater to organizations of all sizes, from global Top 1000 Life Sciences companies to emerging small and mid-sized firms.

References: PRlog, OpenPR, PR.com, 1888pressrelease

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