UDI compliance, in about a minute.

Most GUDID and EUDAMED problems don't start in the database. They start earlier, when device data is spread across ERP systems, label files and someone's spreadsheet. That's why every project starts with a structured data collection template covering 81 data elements per device: identifiers and packaging levels; brand, model and catalog numbers; labeler details; FDA product codes and GMDN terms; sterility, MRI safety and storage; and which changes trigger a new DI. We fill it in with you, check it against your labels, and submit it to GUDID and EUDAMED. Clean data in, accepted records out.

Selling medical devices in the EU? The EUDAMED deadline is November 28, 2026. Reason one: keep your EU market access. Under MDR and IVDR, EUDAMED registration is mandatory: no registration, no EU market. Reason two: build trust and traceability. Every device gets a verified public identity through its UDI. We help with opening your EUDAMED account, quality data collection and submission, UDI assignment, and compliant label design and printing.