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.
Benefits
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.
Lower total cost of ownership and free IT capacity
Go live fast with a 100% browser-based SaaS on SAP BTP (optional SSO via IAS/XSUAA). No SAP backend or local installation is required—no servers, patches, or upgrades to maintain. This cuts infrastructure and admin effort, turns spend into a predictable subscription, and frees scarce IT resources to focus on core projects while meeting EU-region, temporary-processing data expectations.
Standardize regulatory data capture to reduce errors and speed submissions
Utilize ready-to-use templates aligned to MDR/IVDR Annex VI and FDA GUDID. Consistent fields and built-in checks prevent mapping drift so contributors enter the right attributes the first time. The result is fewer errors, less rework, and a faster, more predictable preparation for Unique Device Identification (UDI) submissions.
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.
