Annex II/III trees generated for your risk class with owners and signoff flags, experiment trails where corrections are additions and never overwrites, and pre-clinical pipeline specs that say research-use in every header. Your QA signs; the machine keeps the paperwork honest.
Sections scoped to I/IIa/IIb/III with applicability, owners (client-QA vs documenter) and signoff flags; the gap list is your roadmap.
Attributable, contemporaneous, original-value-preserving entries; corrections append, never overwrite; trail line counts verifiable on delivery.
Ingest→QC→preprocess→model→evaluate→report stages with checks, ethics-approval flag and reproducibility-pack requirements.
Specs and trees carry the label; clinical deployment is your regulated project, not ours.
Signoff flags name your QA per section; we document, you approve.
The trail never hides history — an ALCOA+ invariant enforced by code.
| Service | Model | Price |
|---|---|---|
| Class-scoped gap snapshot (Annex tree + gaps) | one-off, 48 h | CHF 0 |
| MDR tree + gap roadmap (full Annex II/III) | per device | CHF 1,800 |
| ALCOA+ trail setup (+ monthly retention) | one-off + monthly | CHF 900 + 150 |
| Pre-clinical imaging pipeline spec | per modality | CHF 1,500 |
All prices in CHF, excl. VAT where applicable. Swiss QR-bill, net 14 days. Trees include one re-scope after your QA's first review.
A named person replies within 1 business day. The snapshot returns within 48 hours of receiving device class and scope.
The Annex II/III tree for your declared risk class with applicability and gap list — the exact roadmap your QA would otherwise build by hand.
No. Documentation and research-use tooling only; the classification question is answered in writing on every deliverable.
By appending: the original value stays, the correction references it, and both carry actor and timestamp. Overwrites do not exist in the trail format.
No — we prepare structured documentation and evidence packs; the assessment itself is your notified body's job.