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breakpilot-compliance/backend-compliance/knowledge/programs/medical.yaml
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Benjamin Admin 1a9439d013 feat(programs): open Domain Knowledge Program v1 — 7-stage production line + per-domain KPI
The real bottleneck is domain MODELLING. Phase B is organized as one program with sub-programs per
domain, each run through the SAME 7-stage production line. No new runtime framework, no new module
(ADR-009, Freeze v1.0) — only program data + a derived reporting view.

- Customer enters by INDUSTRY, not regulation: Industry -> Domain Model -> Requirement Sources ->
  Requirements -> Capabilities -> ... -> Completeness.
- 7-stage checklist identical for every domain (Domain Model / Requirement Sources / Capability
  Registry / Transition Patterns / Playbooks / Reference Scenarios / Completeness) with per-stage
  ownership. README generalized to the framework.
- Each domain lists typical_requirement_sources + typical_certifications -> pre-onboarding capability
  HYPOTHESIS (the ETO insight; feeds Company 2A as inferred, never confirmed).
- Backlog v1 (by customer value): 1 Industrial Automation, 2 Environmental, 3 Automotive, 4 Medical,
  5 Energy. Five domain-definition shells (environmental restructured to the unified shape, law-first
  preserved).
- Per-domain KPI is DERIVED from the real corpus (computed-not-stored; sources modelled / transition
  patterns / playbooks / reference scenarios), NOT a curated number. Reference suite renders maturity
  bars: Industrial Automation 43% (3/7 sources) leads, Environmental 0% (work ahead). Backlog (value)
  and KPI (corpus state) are deliberately separated.
- ADR-009: Domain Knowledge Program framework. Honest known refinement: regulation-ID normalization
  (CRA vs Cyber Resilience Act) aliased in the KPI.

7 program-contract tests (backlog order + industry-first + derived-not-stored), check-loc 0.
Knowledge data + ADR + reference harness = non-runtime -> no deploy (ADR-001).

Co-Authored-By: Claude Opus 4.7 <noreply@anthropic.com>
2026-06-27 18:49:06 +02:00

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YAML

# Domain Knowledge Program — Medical (backlog rank 4). A domain DEFINITION, not corpus content.
# 7-stage progress is DERIVED from the corpus (computed-not-stored). See programs/README.md.
id: PROG-medical
name: "Medical Domain"
industry: "Medizinprodukte-Hersteller, Medizintechnik"
customer_entry: "Ich baue Medizinprodukte / Medizintechnik."
backlog_rank: 4
rationale: "hoher Leidensdruck (MDR), aber spezialisierter Markt → nach Industrial/Automotive."
status: planned
typical_requirement_sources: [MDR, IEC62304, ISO14971, IEC60601, CRA]
typical_certifications: [ISO13485, ISO14971]
ownership: "Stufe 1 Reasoning · 2 Legal-KG · 3 Execution · 4-7 Reasoning"
note: >
IEC 62304 (Software-Lebenszyklus) ↔ CRA secure-development = quellenübergreifender Convergence-
Kandidat. ISO 14971 (Risikomanagement) ↔ Produkt-Risikoanalyse. Erst nach Industrial/Automotive.