Kvaliteta i regulatorno inženjerstvo
Sustav kvalitete vodi se u repozitoriju kao strojno provjereni registri zahtjeva, opasnosti, mjera i provjera, povezanih međusobno i s kodom. Regulatorna klasifikacija je pravna odluka koja još nije donesena; platforma je građena kao da vrijedi stroži ishod.
Tehnička specifikacija vodi se na engleskom jeziku; naslovi i sažeci poglavlja prevedeni su na hrvatski.
QMS registries
- Requirements
- 126
- Hazards
- 129
- Mitigations
- 121
- Verifications
- 52
- Release gates
- 3
- Monitoring signals
- 16
- Post-market signals
- 12
- Design-history sections
- 8
Each registry is a JSON file with a schema under docs/qms/. The trace matrix links hazards to mitigations, mitigations to verifications, and verifications to the test commands that run them; several of those commands are fail-closed npm wrappers named after their verification ids, so a renamed or deleted test breaks the trace visibly rather than silently.
Standards mapping
- IEC 62304 (software lifecycle)
- How the engineering maps to it
- Planned stages, a design-history index, segregation of deterministic engines from AI drafting, traceable verification
- ISO 14971 (risk management)
- How the engineering maps to it
- Hazard registry with mitigations and verifications; per-feature hazard acceptance packages
- ISO 13485 (quality management)
- How the engineering maps to it
- Design history file sections, change control, complaint and adverse-event workflow, post-market surveillance register
- EU MDR and EU AI Act
- How the engineering maps to it
- A classification memo recording hypotheses pending legal review; the AI feature registry with intended purpose and automation level per feature
- GDPR
- How the engineering maps to it
- DPIAs, a sub-processor register, a PHI data map, a retention policy, erasure engineered for backups
| Standard | How the engineering maps to it |
|---|---|
| IEC 62304 (software lifecycle) | Planned stages, a design-history index, segregation of deterministic engines from AI drafting, traceable verification |
| ISO 14971 (risk management) | Hazard registry with mitigations and verifications; per-feature hazard acceptance packages |
| ISO 13485 (quality management) | Design history file sections, change control, complaint and adverse-event workflow, post-market surveillance register |
| EU MDR and EU AI Act | A classification memo recording hypotheses pending legal review; the AI feature registry with intended purpose and automation level per feature |
| GDPR | DPIAs, a sub-processor register, a PHI data map, a retention policy, erasure engineered for backups |
Claims discipline
A test scans every user-facing string in the client, server and shared code — interface copy, AI prompts, generated exports — against a matrix of forbidden claim patterns — diagnosing, deciding for the clinician, validation claims, automated clinical outputs and outcome guarantees — in English and Croatian. Approved exceptions are listed explicitly. This specification passes it.
Release gates
- Pull-request gate
- Scope
- Every merge
- Runs
- RLS and scoped-access lints, raw-token lint, file-size and any-count ratchets, clinical mock-import gate, dependency audit, typecheck, the instrumented test suite with coverage thresholds, both production builds
- Production release gate
- Scope
- Promotion to production
- Runs
- Everything above plus the Tier-1 evidence benchmark
- Feature hazard acceptance
- Scope
- Per clinical feature
- Runs
- Hazard acceptance packages for operatory, Perio, dispatch, dictation tray and other clinical changes
| Gate | Scope | Runs |
|---|---|---|
| Pull-request gate | Every merge | RLS and scoped-access lints, raw-token lint, file-size and any-count ratchets, clinical mock-import gate, dependency audit, typecheck, the instrumented test suite with coverage thresholds, both production builds |
| Production release gate | Promotion to production | Everything above plus the Tier-1 evidence benchmark |
| Feature hazard acceptance | Per clinical feature | Hazard acceptance packages for operatory, Perio, dispatch, dictation tray and other clinical changes |
docs/qms/regulatory/features/docs/compliance/tests/compliance/medicalClaimsContract.test.tsscripts/medical-release-gate.mjs