EU — EUDAMED (UDI/Device)
Submission‑ready dataset + pre‑check scan + handover pack aligned to the evolving EUDAMED modules.
- Reduce avoidable rejects
- Keep traceability + change control
UDI Ops — Swissdamed / EUDAMED / FDA GUDID
We convert UDI submissions from a rework loop into a repeatable, testable operation: readiness gates, traceability, and handover-ready execution. No sensitive bundles are published. Public demos are anonymized; detailed delivery packs are shared privately.
What makes this operational (not consulting)
Behind the tracks below is an operating layer: one controlled dataset → readiness gates → upload‑ready packages → evidence pack. Public materials stay High-level; implementation details remain shared privately.
Standards & guidance baseline
UDI operations are shaped by jurisdictional requirements (e.g., EU MDR/IVDR) and the evolving state of EUDAMED. We reference official sources and globally harmonized guidance where useful, See Standards & References.
Typical problems
- Missing mandatory information and inconsistent formats
- Contradictions across related entries
- Unclear traceability and review gates
- Packaging ambiguity and fragile handoffs
Outcome
- Less avoidable rework
- Clear readiness picture (done vs blocked)
- Audit‑defensible narrative and handover
- Operational continuity (not person‑dependent)
Engagement model
- Readiness check (1–2 weeks): gaps + priorities + acceptance criteria.
- Implementation sprint (2–6 weeks): repeatable workflow + guide + dry‑run.
- Ongoing ops: controlled updates and change control support.
starter pack
These downloads are kept at a high level. (no enabling implementation details).
UDI submission paths (3-track)
Choose the simplest track that matches your data reality. The goal is fewer rejects, cleaner traceability, and predictable handover.
Track A — Excel templates
Fastest start when your master data is not systematized yet.
- Best for small portfolios and first submissions
- Works across targets (EUDAMED / swissdamed / FDA GUDID) with consistent naming
- Includes a pre-check scan to catch avoidable rejects
Track B — ERP export (e.g., SAP)
Use your system of record, but add readiness gates and validation.
- Best for structured sources and medium scale
- Change control + evidence pack for reviewable approvals
- Handover-ready outputs for internal QA / AR / partners
Targets we optimize for
Current focus: EU EUDAMED (UDI/Device) and CH swissdamed. Other markets can be supported in a roadmap mode (non‑committal, scope‑).
CH — swissdamed (UDI)
Operational submission support built for CH expectations: clean identifiers, predictable updates, audit‑friendly artifacts.
- Structured master data + packaging logic
- Evidence pack suitable for internal QA
US — FDA GUDID (UDI/Device)
GUDID‑ready dataset mapping + validation gates for DI/labeling fields, with audit‑friendly evidence artifacts.
- Consistent identifiers + DI/PI rules
- Traceable change control for recurring updates
Track C — Integration / add-on
When you need recurring updates, multi-target submissions, or high volume.
- Best for high-change environments and multi-market operations
- Automatable validation + structured handoffs
- Focus on stability: fewer surprises and fewer emergency fixes
Pre-check & readiness scan
Before any upload, run a lightweight readiness scan. It reduces rejects and makes reviews faster.
Public downloads are kept at a high level. (no enabling implementation detail).
Quick path finder (30 seconds)
Answer a few questions. We will recommend the simplest track that fits, plus the next action.
Recommended: Track A — Excel templates
Best when data lives across spreadsheets and you need a controlled, submission-ready dataset quickly.
- Start fast with a readiness scan and a clean template
- Reduce rejects with mandatory-field coverage + consistency checks
- Upgrade later to ERP export / integration when volume grows
Next action: download the checklist and book a 20-minute scoping call.
Recommended: Track B — ERP export
Best when you already have a structured system of record, but need validation and traceable review gates.
- Map fields once, then run repeatable pre-checks before submission
- Add evidence packs and change logs for reviewable approvals
- Keep handovers stable across internal QA, AR, and partners
Next action: bring a sample export + target list to a short scoping call.
Recommended: Track C — Integration / add-on
Best when you have high volume, many targets, and recurring updates. The goal is stability.
- Automatable validation + structured handoffs
- Designed for continuous change control (not heroic one-offs)
- Less rework: fewer emergency fixes and fewer rejects
Next action: book a call to align scope, roles, and governance boundaries.
Last updated: 2025-12-20