Modular booking for EUDAMED (UDI, Vigilance/MIR) and FDA (UDI/GUDID, eMDR) – specifically optimized for high data volumes. You upload your data via Excel template; the portal automatically checks for completeness, plausibility, and format, reduces rejections, and accelerates submission. Subsequently, M2M transmission to the authority (where available) takes place – without manual portal steps. You can see the status per submission at any time, receive structured feedback/error texts, and have a clean evidence/audit history.
The Global Submission Portal is a central platform for regulatory submissions that relieves teams in Regulatory Affairs and Quality Management: fewer manual portal steps, better data quality, and a clear overview of the submission status.
The benefits are deliberately formulated for RA/QM – operational, auditable, and traceable.
Do you have SAP and want a fully integrated solution? Then take a look here: GUDI – The SAP UDI Add-on for Global Compliance
Modular according to workflows (EUDAMED / FDA) – with included data volume. Higher volume and enterprise setup on request.
Ideal for starting with one target workflow (EU or US).
For parallel workstreams and growing portfolios.
For global organizations, multiple locations/SRNs and high volume.
You can start with one module today and expand later.
Term: monthly or yearly.
UDI data submission including validation and status overview.
Incident Reporting / MIR workflows with structured processing.
eMDR submission with validation, M2M transmission, and feedback.
UDI-related US workflows with a uniform Excel pattern.
We would be happy to present references and case studies to you in a demo call (after approval).
If you currently have a comparable starting situation (e.g., high UDI count, multiple markets, M2M connection), please let us know the approximate data volume and target modules – then we will show you the appropriate reference.
Stay compliant: The mandatory use of EUDAMED (EU) for medical device registration is approaching. Note the current transition periods:
In Switzerland, registration via swissdamed (CH) is also already mandatory for many actors. Parallel requirements require a synchronous strategy:
We support you in safely meeting both deadlines through automated processes and our combined GSP solution.
Visit us on March 3, 2026, in Tuttlingen. We will be happy to show you our GSP and SAP solutions live on-site!
To regularia 2026Please select at least one module – we will get back to you with a suitable proposal and next steps.