Visu UDI

Visu UDI is a platform developed by DDi for medical device manufacturers that need to manage and submit Unique Device Identification (UDI) data to health authorities across multiple countries. It centralizes Master Data Management (MDM) to ensure device data is accurate, validated, and ready for submission to regulators including the FDA GUDID, EUDAMED, China NMPA, Australia TGA, and others. The platform is designed to address the challenge of data fragmentation that arises when managing UDI requirements country-by-country using spreadsheets, legacy systems, and frequently changing XML standards.

Rather than functioning solely as a publishing or submission tool, Visu UDI is positioned as a data foundation that handles the full workflow from data entry and validation through to country-specific file generation and lifecycle updates. It supports three deployment models to accommodate different organizational sizes and existing infrastructure.

Deployment Models

• XML/XLS conversion only: For organizations with few products, data is maintained in Excel files and uploaded via a simple portal for validation and conversion to XML or XLS format. Available on a pay-per-use basis.
• No existing master data or tools: Includes full master data management functionality as the system of record. Different business functions — product, regulatory, packaging, labeling, UDI — can update data through dedicated screens. A proprietary smartRules engine monitors daily data changes and generates country-specific UDI files when submission criteria are met. Validation failures trigger alerts for manual correction. Lifecycle maintenance is handled within Visu UDI without the need for spreadsheets. Available as a cloud-based, fully validated solution on an annual license model.
• Existing PLM/ERP and other systems: Visu UDI connects to existing source systems via interfaces to pull data changes. All validations are performed and alerts issued for any data issues. Country-specific regulatory, licensing, packaging, labeling, and UDI details can optionally be maintained within Visu if no RIM system is in place. The smartRules engine generates country-specific UDI files based on daily data changes. A machine-to-machine (M2M) submissions gateway is included for automated submissions and acknowledgement management. Available as cloud-based or on-premises deployment.

Compliance and Market Coverage

• Ready-to-use templates for FDA (USA), EUDAMED (EU), NMPA (China), TGA (Australia), and additional markets.
• System rules are updated automatically as global regulations change, covering requirements across Australia, Brazil, Canada, China, the European Union, Japan, Saudi Arabia, Singapore, South Korea, Taiwan, the UK, and the United States.
• Supports compliance with EU MDR and IVDR requirements, including the BUDI-DI group concept and the 109 attributes required for EUDAMED submission.

EUDAMED Submission and Global Submission Gateways

• Direct machine-to-machine (M2M) connectivity for automated EUDAMED submission, removing the need for manual file handling.
• Pre-configured connectors for FDA GUDID (HL7 SPL), China NMPA, and other health authority databases.
• Real-time tracking of submission status with automated handling of acknowledgments (Ack) and error reports (Nack).

Regulatory Data Validation

• Pre-submission validation logic detects missing attributes, format errors, and data inconsistencies before files are submitted to health authorities.
• Validation rules are applied against the specific business rules of each health authority.
• Audit trails maintain a complete history of data changes, user actions, and validation results to support traceability.

Master Data Management (MDM) and RIM Integration

• A SmartMaster component consolidates data from multiple sources into a unified master record.
• UDI data can be linked at the product level with registration certificates, dossiers, and labeling records to provide a complete view of product status.
• Supports integration of UDI data into broader MDM and Regulatory Information Management (RIM) workflows, connecting regulatory affairs, supply chain, and quality teams.

System Integration and Data Syndication

• APIs and connectors support integration with SAP, Oracle, Agile PLM, and major labeling software systems.
• Validated UDI data can be automatically pushed to GDSN data pools and commercial partners without manual intervention.
• Data changes in source systems are pulled into Visu UDI once, with all subsequent validation and submission steps handled by the platform.

Visu UDI is available in both cloud-based and on-premises configurations depending on the deployment model selected. DDi states the platform has over a decade of experience behind it and offers quick onboarding with ongoing global support. Related DDi solutions include a Regulatory Information Management (RIM) platform for medical devices, a Regulatory Impact Assessment (RIA) tool, and dedicated EUDAMED software and consulting services.