Artifakt · Compass · v0.1
EU MDR pathfinder for medical device startups.
Answer ~15 questions. Get a preliminary classification under MDR Annex VIII, a roadmap to CE-marking, an applicable document inventory, a prioritised standards bibliography, a clinical strategy, and an indicative cost / timeline envelope.
Class I and IIa only. Output is preliminary and requires human regulatory review before submission.
Three things founders get wrong about MDR Annex VIII — and what Compass does about each.
01
Deterministic
Annex VIII classification by rule, not by guess. The 22 rules encoded as deterministic logic — no LLM in the decision path.
02
Grounded
Document inventory drawn from the same regulatory corpus the paid Artifakt Tech Doc generator uses. Real MDCG references, real harmonised standards.
03
Hedged
Outputs are preliminary. Every report carries the human-RA-review disclaimer. Compass routes hard-rejection cases (custom-made, IVDR, Annex XV) to expert consultation.
One report. Six outputs. Zero shortcut to a clean MDR pathway.
01
Classification
Class + applicable Annex VIII rule + reasoning chain.
02
Roadmap
Phase plan from QMS setup through CE-marking + post-market.
03
Document inventory
Annex II/III docs that apply — pulled from the BPG V3 mapping.
04
Standards
Harmonised standards (ISO 13485, ISO 14971, ISO 15223-1) + state-of-the-art (IEC 62304, 81001-5-1, 62366-1).
05
Clinical strategy
Equivalence vs investigation vs PMCF-heavy decision tree.
06
Cost & timeline
Indicative ranges per route. NB-variance disclaimer.
Get a preliminary regulatory pathway for your device in five minutes.
Compass writes a founder-readable report covering the entire CE-marking journey from QMS through post-market. No account required. No credit card. The full PDF is email-gated only at the very end.
Compass is a sub-product of Artifakt — a living MedTech compliance system.