Between the obligation and getting it done, there is a gap.

The problem

EUDAMED is a European obligation. But between the obligation and getting it done lies a gap nobody had really addressed: manufacturers' product data lives in Excel files — built up over years, by different teams, following internal logic. EUDAMED expects standardised XML, field by field.

Most manufacturers cross that gap by hand. Re-keying, files rejected without a clear reason, schema versions that change, round trips that last weeks. The regulatory work — the part that needs expertise — ends up buried under data transformation.

Our answer

Let's EUDAMED came out of that observation. Not to replace regulatory expertise, but to give it its time back. The platform takes Excel files as they are, checks every row — mandatory fields, dictionaries, consistencies — and reports each issue with its row, its field and its reason. The XML is generated only once blocking errors are fixed.

Two choices that commit us

We made two choices that commit us. First: start with scoping, never with an account — because a tool handed to unprepared data only produces frustration. Second: offer fully local execution, for organisations whose product data must not leave their infrastructure.

Let's EUDAMED is an independent tool. We are affiliated neither with the European Commission nor with the official portal. Your submissions remain yours. We make their preparation reliable.