Validate EUDAMED and FDA GUDID UDI Excel files in seconds — 100% browser-based on SAP BTP.
Validate Unique Device Identification data for EUDAMED and FDA GUDID before submission. Upload a spreadsheet, get instant row-level feedback (errors/warnings with fix hints), and export a clean report. No customer SAP system required; sign-in via XSUAA/IAS, EU hosting, and temporary processing by default.
Overview
Validate Unique Device Identification (UDI) data faster with row-level feedback
Upload your spreadsheet to get instant row-level feedback with clear fix hints, so teams fix issues in minutes, reduce manual checks, and cut hand-offs. The result is faster preparation, higher first-time-right quality, fewer rework cycles, and an auditable report for collaboration.
Streamline reviews and supplier collaboration to cut cycle time and rework
Ensure mandatory fields, code sets, and cross-table relationships are complete before you submit to authorities. The validator pinpoints missing or conflicting data and produces a clean review report. Fewer rejections and repeat cycles mean higher quality on the first attempt and smoother regulatory interactions.
Export an assignable Excel issue log to shorten review cycles
Export an actionable Excel report listing each issue with record, sheet and message so responsibilities are clear. Stakeholders can filter, assign, and track fixes to closure. Meetings shift from discussion to execution, which speeds remediation and aligns suppliers and internal teams on next steps.
Details
Solution type
Extensions and Add-ons
Industry
Cross-Industry, Life Sciences
Compatibility
Works with
SAP Business Technology Platform
Features
Surface row-level EUDAMED issues with MDR/IVDR rule checks
Apply MDR/IVDR Annex VI rules and immediately surface row-level errors and warnings with clear fix hints. Users see exactly which records and fields must be corrected. Consistent validations reduce manual review effort and create a reliable, repeatable process for preparing UDI submissions.
Apply FDA GUDID business rules with cross-table checks
Enforce FDA GUDID-specific requirements, including mandatory attributes, code tables and cross-table relationships. The validator highlights conflicting selections and missing values with precise messages. RA/QA teams correct issues early, minimizing the risk of rejections and resubmissions.
Export actionable review reports in Excel
Generate a structured report that lists each issue with the affected record, sheet and message. Teams can filter by status, assign owners and track fixes to closure. The report becomes a single source of truth that accelerates remediation and supports sign-off and audit readiness.
Plans and pricing
Standard Edition
EUDAMED rule set (MDR/IVDR Annex VI) with row-level errors/warnings and clear fix hints
Export review report to Excel to filter, share and track issues to closure
Ready-to-use EUDAMED Excel template to standardize data capture and reduce mapping errors
Price unavailable in this region- Minimum contract 1 year
EUDAMED rule set (MDR/IVDR Annex VI) with row-level errors/warnings and clear fix hints
Export review report to Excel to filter, share and track issues to closure
Ready-to-use EUDAMED Excel template to standardize data capture and reduce mapping errors
Basic Edition
FDA GUDID rule set with detailed coverage of mandatory fields, code tables and cross-table checks
Export review report to Excel to filter, share and track issues to closure
Ready-to-use FDA Excel template to standardize data capture and reduce mapping errors
Price unavailable in this region- Minimum contract 1 year
FDA GUDID rule set with detailed coverage of mandatory fields, code tables and cross-table checks
Export review report to Excel to filter, share and track issues to closure
Ready-to-use FDA Excel template to standardize data capture and reduce mapping errors
Advanced Edition
Combined rule sets for EUDAMED and FDA GUDID with row-level errors/warnings and fix hints
Exportable Excel review report for both authorities
Templates for EUDAMED and FDA to standardize data capture
Price unavailable in this region- Minimum contract 1 year
Combined rule sets for EUDAMED and FDA GUDID with row-level errors/warnings and fix hints
Exportable Excel review report for both authorities
Templates for EUDAMED and FDA to standardize data capture
Customer reviews
Technical Information
| Solution type | Extensions and Add-ons |
| Category | Data and Analytics |
| Industry | Cross-Industry, Life Sciences |
| Works with |
SAP Business Technology Platform |
The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
| Deployment |
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| Globalization |
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| Operations |
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The following information is provided by the publisher and applies to the latest app version available on the SAP Store. SAP does not control these policies and procedures; the publisher is solely responsible for the accuracy of the provided information.
| Security |
Encrypted communication channels This product employs encryption to secure all communication channels. |
| Compliance |
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| Privacy policy |
SAP's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner. |
Resources
One-Pager: UDI Excel Cloud Validator for EUDAMED and FDA GUDID
Product Demo – UDI Excel Template
Product Page: UDI Excel Cloud Validator
Publisher
Europe IT Consulting GmbH
Europe IT Consulting GmbH (Basel) is a specialist for MedTech regulatory data solutions and SAP technology. We build and operate products for Unique Device Identification (UDI) and vigilance—incl. EUDAMED (MDR/IVDR), FDA GUDID & eMDR, Swissdamed and TGA—delivered as SAP BTP SaaS and as SAP-integrated add-ons. Our portfolio covers Excel-to-XML tooling, validation services, M2M connectors (AS4/AS2), SAP Fiori apps, and expert consulting. We serve manufacturers, importers and RA/QA teams across Europe and beyond. Quality and security are built in: EU hosting on SAP BTP, XSUAA/IAS, GDPR-aligned data handling, and ISO/SOC certified SAP infrastructure.
