Regulatory automation · Medical devices

EUDAMED bulk upload: from your device list to validated XML, without retyping.

Registering devices and UDI data in EUDAMED one record at a time takes days, and a bulk XML upload fails on a single wrong field. We build the converter that fits your data: your existing Excel or ERP export goes in, validated bulk-upload XML comes out, with every error explained before you upload.

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Where EUDAMED registration usually hurts

What we build for you

En français : nous automatisons l'enregistrement EUDAMED à partir de votre fichier existant (Excel, export ERP ou PLM) : correspondance des colonnes, contrôles ligne par ligne avec des erreurs expliquées, puis fichiers XML de chargement en masse validés. Votre équipe réglementaire garde la main sur le contenu et la soumission ; l'outil peut fonctionner entièrement dans le navigateur. Premier échange gratuit de 30 minutes, puis un pilote à prix fixe sur vos données réelles.

Questions

Can EUDAMED device registrations be uploaded in bulk?
Yes. Besides entering records one by one in the web interface, EUDAMED accepts XML bulk uploads and machine-to-machine data exchange. The difficulty is producing XML that passes validation from the data you already keep.
Do you replace our regulatory team?
No. Your regulatory affairs team owns the content and the submission. We automate the data handling: extraction, mapping, checks and XML generation.
Is AI involved?
No. Regulatory data needs a deterministic, testable process: the same input always gives the same output. This is the fifth of our rules: no AI where a rule-based flow does the job.
How does a project start?
A free 30-minute call, then a fixed-fee pilot on a real export of your data. You keep the code and the runbook.
Book a 30-minute call →