IEC 62304 Software Lifecycle Documentation Mapping — MIME

Scope

MIME is not subject to IEC 62304. It is an open-source research tool, not a medical device. This mapping is provided voluntarily to support downstream SOUP assessment.

Mapping

IEC 62304 Phase	Clause	What the Standard Requires	What MIME Provides	Gaps
Software development planning	5.1	Development plan, standards, tools	ARCHITECTURE_PLAN.md, CONTRIBUTING.md, Git + GitHub CI	No formal development plan in IEC 62304 format. Not required — MIME is not subject to IEC 62304.
Software requirements analysis	5.2	Documented software requirements	ARCHITECTURE_PLAN.md Sections 1–9, MIME_NODE_TAXONOMY.md, test suite	Requirements documented but not in formal specification with IDs and traceability.
Software architectural design	5.3	Architecture document, SOUP identification	ARCHITECTURE_PLAN.md, graph-based architecture, functional purity. MADDENING listed as SOUP dependency.	Architecture well-documented.
Software detailed design	5.4	Detailed design for each software unit	Per-node algorithm documentation in docs/algorithm_guide/, NodeMeta + MimeNodeMeta, Implementation Mapping tables	Coverage grows as algorithm guides are populated.
Software unit implementation	5.5	Implement per detailed design	Source code in src/mime/, NumPy-style docstrings	Formal coding standard in CONTRIBUTING.md.
Software unit verification	5.6	Verify each unit against design	tests/ with B0–B5 verification benchmarks, registered via @verification_benchmark	Coverage grows as benchmarks are implemented.
Software integration testing	5.7	Integration testing	Integration tests within GraphManager, multi-node benchmark scenarios	Present via B1/B4/B5 system-level tests.
Software system testing	5.8	System-level testing	B4–B5 end-to-end benchmarks (full actuation chain + control + uncertainty)	Dependent on Neurobotika mesh.
Software release	5.9	Release documentation, known anomalies	CHANGELOG.md, tagged releases, known_anomalies.yaml, SOUP package	Well-covered once SOUP package is complete.