medharness 0.3.3

Open-source design-controlled development infrastructure for medical device and SaMD teams — includes dhfkit

MedHarness

AI harness and DHF tooling for medical device software teams.

MedHarness structures how AI agents interact with a Design History File under IEC 62304 / FDA-regulated software projects. It pre-computes DHF context before an agent runs, enforces approval gates the agent must pass through, and commits decisions back into the DHF — so the engineer controls the feedback loop, not the agent.

It combines two packages:

• medharness — CLI harness, CI gates, CR workflows, project scaffolding (init)
• dhfkit — standalone DHF engine for items, traceability, document generation, schema validation

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Install

pip install medharness[full]

[full] pulls in optional extras: ai (Gemini-based AI review) and docs (PDF export via WeasyPrint). Omit for a minimal install — the DHF engine (dhfkit) is always included.

Verify:

medharness --help
dhfkit --help

From source (development):

git clone https://github.com/itercharles/MedHarness
cd MedHarness
pip install -e ".[dev]"
pytest dhfkit/tests/ tests/

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Quick Start

medharness init is zero-prompt — it scaffolds a single-repo project in the current directory. The project name is derived from the directory name.

mkdir my-medical-device && cd my-medical-device
python -m venv .venv && source .venv/bin/activate
pip install medharness
medharness init

After init completes, here's what exists on disk:

my-medical-device/                  # single repo — DHF + source together
├── DHF/
│   ├── config/
│   │   ├── global.yaml             # project name, lifecycle states
│   │   └── doc_types/              # one YAML per type (SYS, CRS, SRS, SWDD, CR, …)
│   ├── items/                      # one YAML file per requirement / risk / CR
│   │   ├── 01_crs/                 # Customer Requirements (CRS-NNN.yaml)
│   │   ├── 02_sys/                 # System Requirements (SYS-NNN.yaml)
│   │   ├── 03_srs/                 # Software Requirements (SRS-NNN.yaml)
│   │   ├── 06_cr/                  # Change Requests (CR-NNN.yaml)
│   │   └── ...                     # Use Cases, SOUP, Risk, Defects, etc.
│   ├── test-results/
│   ├── documents/
│   │   ├── specs/                  # Jinja2 spec templates (.j2)
│   │   └── plans/                  # development_plan.md, verification_plan.md, …
│   └── README.md
├── .github/
│   ├── workflows/
│   │   ├── engineering-control.yml # main CI: CR validation + coverage gate + evidence
│   │   ├── cr-analyze.yml          # CR analysis from issues
│   │   ├── cr-develop.yml          # CR development with AI
│   │   ├── cr-spec-iterate.yml     # iterate on spec with review feedback
│   │   ├── cr-transition.yml       # transition CR state in DHF
│   │   ├── cr-complete.yml         # auto-close CR on PR merge
│   │   └── review-pr.yml           # AI-assisted PR review
│   └── prompts/                    # AI prompt templates
├── tests/                          # product test suite
├── CLAUDE.md                       # agent entrypoint
├── .gitignore
└── README.md                       # project README

The scaffolded items are starter samples — replace them with your project's real requirements, architecture, and plans before using this for a regulated product.

Initialize git and push:

git init && git add -A
git commit -m "feat: initialize My Medical Device with MedHarness"
git remote add origin https://github.com/<org>/my-medical-device
git push -u origin main

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How a Change Request flows

Every non-trivial change starts as a Change Request (CR) in the DHF. CRs move through AI-assisted stages, each gated by human approval:

Issue → CR review → analyze-cr → design-cr → develop-cr → cr-complete

Stage	Trigger	What MedHarness does
CR intake	Issue milestoned	Creates CR item in DHF, opens draft PR (cr workflow intake-github-issue-ci)
analyze-cr	CR PR approved	Runs Claude to write a spec, self-corrects against schema, commits to docs/cr-specs/ (ci analyze-cr)
design-cr	Spec PR approved	Runs Claude to create/update DHF items, validates schema + traceability (ci design-cr)
develop-cr	Design PR approved	Runs Claude to implement code, opens implementation PR (ci develop-cr)
cr-complete	PR merged	Transitions CR to completed in the DHF (cr workflow complete-from-github-pr)

When a PR receives review feedback, re-run the same command with --pr N to revise the existing output based on reviewer comments.

The workflow YAML files for each stage are scaffolded by medharness init into .github/workflows/.

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Test Coverage Gate

The CI gate (medharness ci test-coverage) enforces that every verifiable requirement has at least one passing test linked to it.

JUnit XML contract

Tests must emit JUnit XML with properties linking to DHF item IDs:

<testcase name="test_TC_SYS_005_001_validates_link_format">
  <properties>
    <property name="medharness.id" value="TC-SYS-005-001"/>
    <property name="medharness.links" value="SYS-005"/>
  </properties>
</testcase>

All property names are defined as constants in medharness/contracts.py:

Property	Purpose
medharness.id	Test case identifier (e.g. TC-SYS-005-001)
medharness.links	Comma-separated DHF item IDs the test covers
medharness.title	Human-readable test title (optional)
medharness.reviewer	Reviewer name (optional)
medharness.review_date	Review date (optional)
medharness.review_status	Review status (optional)

Python / pytest

Use pytest's record_property in conftest.py:

@pytest.fixture(autouse=True)
def _inject_medharness_metadata(request, record_property):
    doc = request.function.__doc__ or ""
    tc_id = extract_tc_id_from_name(request.node.name)
    links = parse_links(doc)   # extract @links:SYS-005 from docstring
    if tc_id:
        record_property("medharness.id", tc_id)
    if links:
        record_property("medharness.links", ",".join(links))

TypeScript / Vitest / Playwright

Use custom JUnit reporters that emit <properties> blocks for medharness.links. Reference implementations are available in the WebTPS repo.

Running the gate locally

# From project root
pytest tests/ -q --junitxml=test-results/results.xml
medharness --dhf DHF ci test-coverage --junit-dir test-results

Expect output like:

[test-coverage] SRS: 12/14 covered
      ↳ uncovered: SRS-012
      ↳ uncovered: SRS-008

The command exits non-zero when gaps exist, blocking CI.

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CLI Reference

Scaffold

medharness init                     # zero-prompt single-repo project setup

DHF operations (run with --dhf DHF)

medharness --dhf DHF dhf item list --type SYS
medharness --dhf DHF dhf item get SYS-001
medharness --dhf DHF dhf item create --type SYS --data '{"title": "My req"}'
medharness --dhf DHF dhf item update SYS-001 --data '{"title": "Updated"}'
medharness --dhf DHF dhf item delete SYS-001
medharness --dhf DHF dhf item transitions CR-001
medharness --dhf DHF dhf item transition CR-001 approved --by "Alice"
medharness --dhf DHF dhf validate schema
medharness --dhf DHF dhf validate traceability
medharness --dhf DHF dhf doc list
medharness --dhf DHF dhf doc generate SYS
medharness --dhf DHF dhf doc export SYS          # PDF output (requires `[docs]`)
medharness --dhf DHF dhf test list
medharness --dhf DHF dhf config doc-types

CI gates

medharness ci dhf-validate --dhf DHF
medharness ci test-coverage --dhf DHF --junit-dir test-results
medharness ci evidence bundle --dhf DHF --out-dir artifacts

CR generation commands

Encapsulate the full AI loop for each CR stage: prompt assembly (with embedded DHF impact skills) → claude -p invocation → validate → self-correct.

# Initial generation
medharness --dhf DHF ci analyze-cr --cr CR-034   # write docs/cr-specs/CR-034-Spec.md
medharness --dhf DHF ci design-cr  --cr CR-034   # create/update DHF items
medharness --dhf DHF ci develop-cr --cr CR-034   # implement code

# Revision based on PR review feedback
medharness --dhf DHF ci analyze-cr --cr CR-034 --pr 42
medharness --dhf DHF ci design-cr  --cr CR-034 --pr 42
medharness --dhf DHF ci develop-cr --cr CR-034 --pr 42

ANTHROPIC_MODEL env var selects the Claude model. GH_TOKEN is required when --pr is used (fetches review comments from the GitHub API).

Each command outputs JSON to stdout:

{ "cr_id": "CR-034", "spec_path": "docs/cr-specs/CR-034-Spec.md",
  "status": "ok", "corrections": 0, "validation": "passed" }

CR workflow commands

medharness cr workflow intake-github-issue-ci      # CR intake from issue
medharness cr workflow complete-from-github-pr     # CR completion on PR merge

Agent session helpers

medharness ci claude-session put <pr_number> <session_id>
medharness ci claude-session get <pr_number>

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Python API

Use DHFClient for high-level operations (recommended for product repo automation):

from medharness.client import DHFClient

client = DHFClient(Path("DHF"))

cr   = client.get_item("CR-034")
spec = client.get_cr_context("CR-034")   # {"cr": {...}, "spec": "..."}
client.transition_item("CR-034", "in_review", performed_by="alice")

Or use dhfkit standalone (no dependency on medharness):

from dhfkit.local_adapter import LocalDHFAdapter

adapter = LocalDHFAdapter(Path("DHF"))
items  = adapter.list_items("SRS")

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Repository layout

Directory	Purpose
medharness/	CLI harness, CI gates, CR workflows, init scaffolding
dhfkit/	DHF engine: items, lifecycle, traceability, document generation
dhfkit/templates/	Starter DHF scaffold — config, specs, plans, sample items, CI workflows
tests/	MedHarness and dhfkit test suites
docs/	Architecture, ADRs, compatibility contracts

dhfkit has no dependency on medharness — the engine can be used standalone.

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Docs

• docs/architecture.md — packages, scaffold model, DHF lifecycle
• docs/compatibility-contracts.md — stable public contracts
• docs/adr/ — architecture decision records
• CHANGELOG.md — version history

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License

MIT — see LICENSE.