medharness 0.1.0__tar.gz

medharness-0.1.0/LICENSE

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+MIT License
+
+Copyright (c) 2025 CompliantFlow contributors
+
+Permission is hereby granted, free of charge, to any person obtaining a copy
+of this software and associated documentation files (the "Software"), to deal
+in the Software without restriction, including without limitation the rights
+to use, copy, modify, merge, publish, distribute, sublicense, and/or sell
+copies of the Software, and to permit persons to whom the Software is
+furnished to do so, subject to the following conditions:
+
+The above copyright notice and this permission notice shall be included in all
+copies or substantial portions of the Software.
+
+THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR
+IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY,
+FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE
+AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER
+LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM,
+OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE
+SOFTWARE.

medharness-0.1.0/PKG-INFO

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+Metadata-Version: 2.4
+Name: medharness
+Version: 0.1.0
+Summary: Open-source design-controlled development infrastructure for medical device and SaMD teams — includes dhfkit
+Author: MedHarness Contributors
+License: MIT
+Project-URL: Homepage, https://github.com/itercharles/MedHarness
+Project-URL: Source, https://github.com/itercharles/MedHarness
+Project-URL: Bug Tracker, https://github.com/itercharles/MedHarness/issues
+Project-URL: Documentation, https://github.com/itercharles/MedHarness#readme
+Keywords: medical-device,iec-62304,iso-14971,iec-82304-1,dhf,design-history-file,traceability,compliance,samd
+Classifier: Development Status :: 3 - Alpha
+Classifier: Intended Audience :: Healthcare Industry
+Classifier: Intended Audience :: Developers
+Classifier: License :: OSI Approved :: MIT License
+Classifier: Operating System :: OS Independent
+Classifier: Programming Language :: Python :: 3 :: Only
+Classifier: Programming Language :: Python :: 3.11
+Classifier: Programming Language :: Python :: 3.12
+Classifier: Topic :: Software Development :: Quality Assurance
+Requires-Python: >=3.11
+Description-Content-Type: text/markdown
+License-File: LICENSE
+Requires-Dist: pydantic>=2.0
+Requires-Dist: click
+Requires-Dist: networkx
+Requires-Dist: pyyaml
+Requires-Dist: python-frontmatter
+Requires-Dist: jinja2
+Requires-Dist: python-docx
+Requires-Dist: gitpython
+Requires-Dist: python-dateutil
+Requires-Dist: python-dotenv
+Requires-Dist: markdown
+Provides-Extra: ai
+Requires-Dist: google-genai; extra == "ai"
+Provides-Extra: docs
+Requires-Dist: weasyprint; extra == "docs"
+Provides-Extra: dev
+Requires-Dist: pytest; extra == "dev"
+Requires-Dist: pytest-cov; extra == "dev"
+Provides-Extra: full
+Requires-Dist: medharness[ai,docs]; extra == "full"
+Dynamic: license-file
+
+# MedHarness
+
+**AI harness and DHF tooling for medical device software teams.**
+
+MedHarness is an open-source framework for building AI-driven engineering workflows on IEC 62304 /
+FDA-regulated software projects. It combines two things:
+
+1. **`medharness`** — a CI harness that structures how AI agents (Claude Code) interact with a
+   Design History File: pre-computing context, enforcing approval gates, persisting decisions,
+   and generating audit-ready evidence.
+
+2. **`dhfkit`** — a standalone DHF engine for managing items, enforcing traceability
+   (UC → CRS → SRS → SWDD → TC), validating schema, and generating specification documents.
+
+[![License: MIT](https://img.shields.io/badge/License-MIT-yellow.svg)](LICENSE)
+[![Python 3.11+](https://img.shields.io/badge/python-3.11+-blue.svg)](https://python.org)
+
+> **Harness engineering:** Rather than prompting an AI to "do compliance," MedHarness
+> pre-computes the DHF context, injects it into the agent environment, defines approval gates
+> the agent must pass through, and captures the agent's decisions back into the DHF — so the
+> engineer controls the loop, not the agent.
+
+---
+
+## Install
+
+```bash
+# From source (not yet on PyPI):
+git clone https://github.com/itercharles/MedHarness
+cd MedHarness
+pip install -e .
+```
+
+Verify:
+
+```bash
+medharness --help
+dhfkit --help
+```
+
+---
+
+## Quick Start
+
+```bash
+medharness init
+```
+
+Interactively scaffolds two repos:
+
+- **DHF repo** — `DHF/config/`, item YAML templates, spec/plan Jinja2 templates,
+  GitHub Actions workflows for CR analysis, design, and CI validation
+- **Product repo files** — `CLAUDE.md`, `engineering-control.yml`, `cr-complete.yml`,
+  Claude Code skills (`.claude/skills/`)
+
+---
+
+## How it works
+
+A Change Request flows through five AI-assisted stages, each enforced by GitHub Actions:
+
+```
+Issue → cr-analyze (AI spec) → cr-design (AI DHF items) → cr-develop (AI code) → cr-complete
+```
+
+At each stage MedHarness:
+- **Pre-computes DHF context** (`medharness dhf context overview`) and injects it as `$DHF_CONTEXT`
+- **Runs Claude** with `--dangerously-skip-permissions` inside the DHF repo
+- **Commits transitions** back to the DHF (`medharness dhf item transition --commit --push`)
+- **Stores session IDs** in PR comments for iterative review (`medharness ci claude-session put/get`)
+
+---
+
+## CLI surface
+
+```
+medharness init
+
+# DHF operations (run from DHF repo with --dhf DHF)
+medharness --dhf DHF dhf item list|get|create|update|delete|transitions|transition
+medharness --dhf DHF dhf validate schema|traceability
+medharness --dhf DHF dhf doc list|generate|export
+medharness --dhf DHF dhf test list
+medharness --dhf DHF dhf context overview|implementation
+medharness --dhf DHF dhf config doc-types
+
+# CI gates (run from product repo)
+medharness ci dhf-validate --dhf DHF
+medharness ci test-coverage --dhf DHF
+medharness ci evidence bundle --dhf DHF --out-dir ...
+medharness ci artifacts generate --dhf DHF --out-dir ...
+
+# GitHub Actions helpers
+medharness ci github-event --github-output "$GITHUB_OUTPUT"
+medharness ci claude-session put <pr_number> <session_id>
+medharness ci claude-session get <pr_number>
+
+# CR workflow
+medharness cr workflow intake-github-issue-ci
+medharness cr workflow complete-from-github-pr
+```
+
+---
+
+## Python API
+
+Use `dhfkit` directly in product repo automation without shelling out:
+
+```python
+from medharness.client import DHFClient
+
+client = DHFClient(Path("../my-project-DHF/DHF"))
+cr = client.get_item("CR-034")
+context = 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`):
+
+```python
+from dhfkit.local_adapter import LocalDHFAdapter
+
+adapter = LocalDHFAdapter(Path("DHF"))
+items = adapter.list_items("SRS")
+```
+
+---
+
+## 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 |
+| `docs/` | Architecture, ADRs, compatibility contracts, roadmap |
+
+`dhfkit` has no dependency on `medharness` and can be used standalone.
+
+---
+
+## Docs
+
+- [docs/roadmap.md](docs/roadmap.md) — vision and milestone plan
+- [docs/architecture.md](docs/architecture.md) — packages, scaffold model, DHF lifecycle
+- [docs/compatibility-contracts.md](docs/compatibility-contracts.md) — stable public contracts
+- [docs/adr/](docs/adr/) — architecture decision records
+- [CHANGELOG.md](CHANGELOG.md) — version history
+
+---
+
+## License
+
+MIT — see [LICENSE](LICENSE).

medharness-0.1.0/README.md

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+# MedHarness
+
+**AI harness and DHF tooling for medical device software teams.**
+
+MedHarness is an open-source framework for building AI-driven engineering workflows on IEC 62304 /
+FDA-regulated software projects. It combines two things:
+
+1. **`medharness`** — a CI harness that structures how AI agents (Claude Code) interact with a
+   Design History File: pre-computing context, enforcing approval gates, persisting decisions,
+   and generating audit-ready evidence.
+
+2. **`dhfkit`** — a standalone DHF engine for managing items, enforcing traceability
+   (UC → CRS → SRS → SWDD → TC), validating schema, and generating specification documents.
+
+[![License: MIT](https://img.shields.io/badge/License-MIT-yellow.svg)](LICENSE)
+[![Python 3.11+](https://img.shields.io/badge/python-3.11+-blue.svg)](https://python.org)
+
+> **Harness engineering:** Rather than prompting an AI to "do compliance," MedHarness
+> pre-computes the DHF context, injects it into the agent environment, defines approval gates
+> the agent must pass through, and captures the agent's decisions back into the DHF — so the
+> engineer controls the loop, not the agent.
+
+---
+
+## Install
+
+```bash
+# From source (not yet on PyPI):
+git clone https://github.com/itercharles/MedHarness
+cd MedHarness
+pip install -e .
+```
+
+Verify:
+
+```bash
+medharness --help
+dhfkit --help
+```
+
+---
+
+## Quick Start
+
+```bash
+medharness init
+```
+
+Interactively scaffolds two repos:
+
+- **DHF repo** — `DHF/config/`, item YAML templates, spec/plan Jinja2 templates,
+  GitHub Actions workflows for CR analysis, design, and CI validation
+- **Product repo files** — `CLAUDE.md`, `engineering-control.yml`, `cr-complete.yml`,
+  Claude Code skills (`.claude/skills/`)
+
+---
+
+## How it works
+
+A Change Request flows through five AI-assisted stages, each enforced by GitHub Actions:
+
+```
+Issue → cr-analyze (AI spec) → cr-design (AI DHF items) → cr-develop (AI code) → cr-complete
+```
+
+At each stage MedHarness:
+- **Pre-computes DHF context** (`medharness dhf context overview`) and injects it as `$DHF_CONTEXT`
+- **Runs Claude** with `--dangerously-skip-permissions` inside the DHF repo
+- **Commits transitions** back to the DHF (`medharness dhf item transition --commit --push`)
+- **Stores session IDs** in PR comments for iterative review (`medharness ci claude-session put/get`)
+
+---
+
+## CLI surface
+
+```
+medharness init
+
+# DHF operations (run from DHF repo with --dhf DHF)
+medharness --dhf DHF dhf item list|get|create|update|delete|transitions|transition
+medharness --dhf DHF dhf validate schema|traceability
+medharness --dhf DHF dhf doc list|generate|export
+medharness --dhf DHF dhf test list
+medharness --dhf DHF dhf context overview|implementation
+medharness --dhf DHF dhf config doc-types
+
+# CI gates (run from product repo)
+medharness ci dhf-validate --dhf DHF
+medharness ci test-coverage --dhf DHF
+medharness ci evidence bundle --dhf DHF --out-dir ...
+medharness ci artifacts generate --dhf DHF --out-dir ...
+
+# GitHub Actions helpers
+medharness ci github-event --github-output "$GITHUB_OUTPUT"
+medharness ci claude-session put <pr_number> <session_id>
+medharness ci claude-session get <pr_number>
+
+# CR workflow
+medharness cr workflow intake-github-issue-ci
+medharness cr workflow complete-from-github-pr
+```
+
+---
+
+## Python API
+
+Use `dhfkit` directly in product repo automation without shelling out:
+
+```python
+from medharness.client import DHFClient
+
+client = DHFClient(Path("../my-project-DHF/DHF"))
+cr = client.get_item("CR-034")
+context = 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`):
+
+```python
+from dhfkit.local_adapter import LocalDHFAdapter
+
+adapter = LocalDHFAdapter(Path("DHF"))
+items = adapter.list_items("SRS")
+```
+
+---
+
+## 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 |
+| `docs/` | Architecture, ADRs, compatibility contracts, roadmap |
+
+`dhfkit` has no dependency on `medharness` and can be used standalone.
+
+---
+
+## Docs
+
+- [docs/roadmap.md](docs/roadmap.md) — vision and milestone plan
+- [docs/architecture.md](docs/architecture.md) — packages, scaffold model, DHF lifecycle
+- [docs/compatibility-contracts.md](docs/compatibility-contracts.md) — stable public contracts
+- [docs/adr/](docs/adr/) — architecture decision records
+- [CHANGELOG.md](CHANGELOG.md) — version history
+
+---
+
+## License
+
+MIT — see [LICENSE](LICENSE).

medharness-0.1.0/dhfkit/__init__.py

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+"""dhfkit — standalone data-layer package for DHF repositories.
+
+Public API
+----------
+Shared data types (safe to import anywhere):
+    Item, ProjectConfig, DocTypeConfig, ValidationError
+
+DHF I/O utilities (for direct DHF-layer consumers such as tests and adapters):
+    ItemLoader, ResultStore, parse_junit_xml, ExecutionResult
+
+Internal (not part of the public API):
+    ItemSaver, GitRepository, DocumentGenerator
+    — these are implementation details of the adapter layer.
+"""
+
+from dhfkit.models.item import Item
+from dhfkit.models.config import ProjectConfig, DocTypeConfig
+from dhfkit.exceptions import ValidationError
+from dhfkit.result_store import ResultStore
+from dhfkit.junit_parser import parse_junit_xml, ExecutionResult
+from dhfkit.repository.loader import ItemLoader
+from dhfkit.artifact_fetcher import GitHubArtifactFetcher
+from dhfkit.local_adapter import LocalDHFAdapter
+
+__all__ = [
+    "Item",
+    "ProjectConfig",
+    "DocTypeConfig",
+    "ValidationError",
+    "ResultStore",
+    "parse_junit_xml",
+    "ExecutionResult",
+    "ItemLoader",
+    "GitHubArtifactFetcher",
+    "LocalDHFAdapter",
+]

medharness-0.1.0/dhfkit/__main__.py

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+"""dhfkit standalone CLI entry point."""
+from dhfkit.cli import main
+
+if __name__ == "__main__":
+    main()

medharness-0.1.0/dhfkit/api.py

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+"""dhfkit API — reusable Python functions for DHF operations.
+
+All functions accept a DHF root path and return structured data.
+No Click, no stdout/stderr, no CLI concerns.
+"""
+
+from pathlib import Path
+from typing import Optional
+
+from dhfkit.local_adapter import LocalDHFAdapter
+
+
+def _adapter(dhf_root: Path) -> LocalDHFAdapter:
+    return LocalDHFAdapter(dhf_root, auto_commit=False)
+
+
+# -- Item operations ----------------------------------------------------------
+
+def get_item(dhf_root: Path, item_id: str) -> Optional[dict]:
+    return _adapter(dhf_root).get_item(item_id)
+
+
+def list_items(dhf_root: Path, doc_type: Optional[str] = None) -> list[dict]:
+    return _adapter(dhf_root).list_items(doc_type)
+
+
+def create_item(dhf_root: Path, data: dict, author: str = "system",
+                cr_id: Optional[str] = None) -> dict:
+    return _adapter(dhf_root).create_item(data, author=author, cr_id=cr_id)
+
+
+def update_item(dhf_root: Path, item_id: str, data: dict,
+                author: Optional[str] = None,
+                cr_id: Optional[str] = None) -> Optional[dict]:
+    return _adapter(dhf_root).update_item(item_id, data, author=author, cr_id=cr_id)
+
+
+def delete_item(dhf_root: Path, item_id: str, author: Optional[str] = None) -> bool:
+    return _adapter(dhf_root).delete_item(item_id, author=author)
+
+
+def get_item_transitions(dhf_root: Path, item_id: str) -> list[dict]:
+    return _adapter(dhf_root).get_available_transitions(item_id)
+
+
+def transition_item(dhf_root: Path, item_id: str, to_state: str,
+                    performed_by: Optional[str] = None) -> dict:
+    return _adapter(dhf_root).execute_transition(item_id, to_state, performed_by=performed_by)
+
+
+# -- Validation operations ----------------------------------------------------
+
+def validate_schema(dhf_root: Path) -> dict:
+    return _adapter(dhf_root).validate_schema()
+
+
+def validate_traceability(dhf_root: Path) -> dict:
+    return _adapter(dhf_root).validate_traceability()
+
+
+# -- Document operations ------------------------------------------------------
+
+def list_doc_types(dhf_root: Path) -> list[str]:
+    return _adapter(dhf_root).get_available_doc_types()
+
+
+def generate_doc(dhf_root: Path, doc_type_code: str) -> dict:
+    return _adapter(dhf_root).generate_doc(doc_type_code)
+
+
+def export_pdf(dhf_root: Path, doc_type_code: str) -> dict:
+    return _adapter(dhf_root).export_pdf(doc_type_code)
+
+
+# -- Test result operations ---------------------------------------------------
+
+def get_test_status(dhf_root: Path, tc_id: str) -> Optional[dict]:
+    return _adapter(dhf_root).get_test_result(tc_id)
+
+
+def list_test_results(dhf_root: Path, status_filter: Optional[str] = None) -> dict[str, dict]:
+    return _adapter(dhf_root).get_all_test_results(status_filter)
+
+
+# -- Config operations --------------------------------------------------------
+
+def list_doc_type_configs(dhf_root: Path) -> list[dict]:
+    return _adapter(dhf_root).list_item_types()