The central solution for your UDI compliance – specifically optimized for high data volumes. Directly in SAP. No interface chaos. Centralize master data in the Global Master and submit via plug-in to EUDAMED, FDA, NMPA & more. Validated, secure, and fully integrated.
GUDI is the SAP add-on that turns your ERP into the "Single Source of Truth" for regulatory submissions.
Combines compliance assurance with IT stability.
You don't use SAP and want a fully integrated solution? Then take a look here: Global Submission Portal (GSP) – The flexible UDI solution for high data volumes.
Transparent based on the number of regulatory authority plug-ins. Optimized for high data volumes.
Ideal for getting started in a target market.
Leverage synergies (e.g., EU + US).
For global rollouts & high volume.
Stay compliant: The mandatory use of EUDAMED (EU) for registering medical devices is getting closer. Please note the current transition deadlines:
In Switzerland, too, many stakeholders are already subject to mandatory registration via swissdamed (CH). The parallel requirements call for an integrated strategy:
GUDI helps you reliably meet both deadlines through automated processes directly in your SAP system.
Choose your target markets. The logic remains the same: Common data in the Master, specific data in the Plug-in.
MDR/IVDR Compliance. Basic UDI-DI & UDI-DI Management.
Automated MIR Reports.
UDI Submission Class I, II, III incl. GMN Management.
Automated eMDR Reports.
Specific requirements for the Chinese market.
Specific requirements for the Australian market.
Connection to the Saudi Food & Drug Authority Registry.
Product Tracking System Notifications (Turkey).
Visit us on March 3, 2026 in Tuttlingen. We’ll be happy to show you our SAP and GSP solutions live on site!
Configure your interest. We will get back to you with a proposal.