Module spotlight: UDI, GUDID & EUDAMED
Modern device regulation runs on identification and databases. UDI records plus GUDID and EUDAMED data, kept ready for submission, keep your device identity consistent across markets.
By MoniDoseQMS Team
Unique Device Identification is the backbone of modern traceability — the system that lets a device be tracked from manufacture to use, across borders and databases. Managing UDI records, GUDID data for the FDA, and EUDAMED data for the EU keeps your device identity accurate everywhere it needs to be.
What you can do
- Maintain UDI records for your devices
- Prepare GUDID data for the United States
- Keep EUDAMED data ready for the European Union (no direct API upload)
- Keep device identity consistent across markets and submissions
Why it matters
EU MDR and FDA rules both mandate UDI and database registration. Handling them inside the QMS — linked to technical documentation and registrations — avoids the duplicate data entry and mismatches that cause submission delays.
See how MoniDoseQMS handles this
Book a 30-minute demo, or request a 14-day trial. Trial accounts are activated after a short review.