UDI Excel Cloud Validator
Validate UDI Excel for EUDAMED and FDA GUDID—fast, precise, and fully in the cloud.
The UDI Excel Cloud Validator helps MedTech teams catch format and content issues before submission. You sign in via browser, select the target authority, and upload your Excel file. Within seconds, the app returns row-level feedback with clear hints on how to fix each finding. When you’re ready, you can download a detailed Excel or CSV report for review and collaboration.
What it does
The solution verifies UDI data sets for both EUDAMED (MDR/IVDR Annex VI) and FDA GUDID against up-to-date business rules. Users can start with a ready-to-use template or validate their own files, and the service highlights missing fields, inconsistent values, and rule conflicts directly at record level. Because the app runs on SAP Business Technology Platform, no customer system or local installation is required; everything happens securely in the cloud.
How It Works
After login you choose the authority—EUDAMED or FDA GUDID—optionally download the blank template, and upload your populated Excel. The Validator processes the file, merges the sheets, and evaluates every record. Errors and warnings appear instantly with human-readable messages so that teams can correct them right away. A comprehensive report is available for download to track fixes and to share with colleagues or suppliers.
Why it matters
Preparing UDI data is time-critical and often iterative. The Validator reduces manual review effort, shortens rework cycles, and raises first-time-right quality by turning vague rejections into actionable guidance. Teams gain speed and confidence without having to deploy additional software or touch their ERP landscape, which is especially useful for manufacturers and importers who do not run SAP or who are working outside of their productive systems.
Editions and licensing
You can subscribe to the edition that fits your pathway: an EUDAMED-only edition for EU submissions, an FDA-only edition for GUDID, or a combined edition that covers both authorities in a single plan. Each edition includes access to templates, instant validation in the browser, and exportable results. Commercial details and contract terms are provided during onboarding.
Designed for your team
Regulatory Affairs and Quality groups use the Validator to pre-check master data, Supplier Quality teams rely on it to validate vendor files before intake, and project leads employ it to enforce a consistent template across countries and product lines. The app’s simple flow keeps training minimal while its reports provide enough depth for audits and internal reviews.
Getting started
Request access, sign in with the credentials we provide, and validate your first file within minutes. If you prefer a walk-through, book a live demo and we will guide you through templates, validation results, and reporting using your sample data.
Are you interested?