UDI Submission Readiness Checklist
High-level readiness scan categories to spot avoidable gaps.
Version: v1.1
Resources
downloads for RA/QA teams (no tracking, no enabling disclosure). No client data, no sensitive bundles. These resources are kept at a high level.
UDI Ops One‑Pager
A compact delivery model overview.
Version: v1.1
Integrity
Verify downloads using integrity manifests (audit-friendly).
News
Short, updates. For current build and integrity artifacts, see Status.
Updated via news.json
EUDAMED primer
Source-linked orientation for RA/QA teams: definition, scope, key dates, and preparation.
swissdamed primer
What swissdamed is, who must register, how it aligns with EUDAMED, and what to prepare.
Verify integrity (≈ 1 minute)
Public PDFs are published with an integrity manifest + checksums. Compare SHA‑256 of your download to the published values.
macOS / Linux
shasum -a 256 "FWL_YourFile.pdf"
Windows (PowerShell)
Get-FileHash "FWL_YourFile.pdf" -Algorithm SHA256
Last updated: 2025-12-20