All BioFlow product requirements live here, authored in StrictDoc.

1. Layout

The requirements graph is split across three specification tiers (matching the IEC 62304 §5.2 + §5.3 V-model layout) plus three test-spec documents:

• 10_system.sdoc — System / stakeholder requirements (prefix SYS-). Device-level commitments — what the device, as a whole, must do. Maps to ISO/IEC/IEEE 29148 System Requirements.
• 11_srs.sdoc — Software Requirements Specification (prefix SRS-). Software-level requirements — what the software must do. Maps to IEC 62304 §5.2 Software Requirements.
• 20_architecture.sdoc — Software Architecture Description (prefix ARCH-). Architectural elements — subsystems, interfaces, SOUP, segregation. Maps to IEC 62304 §5.3 Software Architecture.
• 30_unit_tests.sdoc — Unit test specifications (prefix UT-).
• 31_integration_tests.sdoc — Integration test specifications (prefix IT-).
• 32_system_tests.sdoc — System test specifications (prefix ST-).
• strictdoc_config.py — StrictDoc project configuration.

A fourth tier for §5.4 Detailed Design is intentionally absent — Class B does not require it. (See dev-docs/strictdoc.md and the strictdoc-requirements skill for the full rationale.)

2. Authoring

Each .sdoc document's [GRAMMAR] block enforces field shapes, the TYPE vocabulary, and the typed-link roles at parse time. For all authoring rules — tier selection, TYPE classification, verification minimums, completeness checklist — see .claude/skills/strictdoc-requirements/SKILL.md.

Change records for edits to baselined items live in changes/ (see changes/README.md).

3. Running StrictDoc

Developer-facing install, export, web-UI, version-bump, and SOUP details are in dev-docs/strictdoc.md. Short version:

uv sync                                                    # install
uv run strictdoc export regulatory-docs/ --output-dir regulatory-docs/output     # export HTML