EUDAMED primer
What EUDAMED is, what changes over time, and how to stay submission‑ready.
Knowledge center
Short, High-level primers and decision aids for RA/QA teams. References point to official sources; delivery packs remain shared privately.
Fastest path
If you have a timeline and constraints, send a short brief. We reply with the minimum next steps (scope + evidence + turnaround).
Principles
- Single source of truth (one controlled dataset, many outputs)
- Readiness gates (done vs blocked, acceptance criteria)
- Audit narrative (traceability, change control, handover)
Guides & primers
Operating layer (overview)
A short, high-level explanation of the engine: how we turn a controlled dataset into validated, submission‑ready outputs and audit‑friendly handovers.
SRN / Actor registration
Who needs SRN, what to prepare, and typical failure modes.
swissdamed primer
High‑level view of swissdamed expectations and operational support boundaries.
UDI Ops overview
Operating model, targets, and the 3‑track submission paths.
Timelines (overview)
Keep a calm view of what is mandatory vs evolving—without over‑promising dates.
Standards & references
Official sources and harmonized guidance curated for fast lookup.
Checklists & downloads
UDI submission readiness checklist
A fast scan to spot avoidable gaps before you submit.
UDI Ops one‑pager
An executive summary for internal alignment.
Integrity manifests
Audit‑friendly verification (manifest + checksums).
Note
Public materials are kept at a high level. Implementation details are provided only in scoped, shared privately delivery packs.