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iec62304-writer

v0.15.0

IEC 62304 class A technical-file pipeline — SRS, SDS, STD, traceability, safety (ISO 14971 §C.2 causal chain + §7.2 control hierarchy + §7.4 quantitative residual + §7.5 cascade), production, cyber (IEC 81001-5-1) and usability (IEC 62366-1 — UEF + Summative Evaluation + IECEE checklist, platform-rich and clinical-narrow modes) risk analyses, incremental update, RAQA-ready exports (SRS + SDD + STP + STDR + STR + Risk Analysis Report + Risk Table xlsx + UEF + USE + UEF-Annex1), and a submission contract (normative vs internal sections, requirement kinds, parameter registry, OTS registry, cybersecurity architecture views) enforced by a gated --release export. Reproduces locally the useful features of Matrix Requirements.

Claude Code22 Skills

By cyrou131 GitHub starsUpdated 2 weeks ago

Directory evidence

Runtimes
Claude Code
Parsed components
22 skill or MCP entries
Source updated
Sep 6, 2026
Manifest status
Canonical path parsed

The directory validates manifest shape and source location. It does not execute the plugin or provide a security endorsement. Review the indexing methodology →

Install iec62304-writer for Claude Code

Installs for the current user
claude plugin marketplace add IchenDEV/agent-plugin-mkt
claude plugin marketplace update agent-plugin-marketplace
claude plugin install iec62304-writer@agent-plugin-marketplace

Paste and run these commands in a terminal with Claude Code. They add and refresh the PluginsMP catalog, then install this plugin.

The installer fetches third-party code from the source repository shown on this page. This directory validates manifest structure and source location, but does not perform a security audit; review the manifest, components, and source before installing.

Get the source manually
git clone https://github.com/cyrou13/technical-writer

Clone the source repository, then follow its setup instructions to add the plugin to a compatible client. The plugin root is plugins/iec62304-writer/.

Plugin files

plugins/iec62304-writer/
├── .claude-plugin/plugin.json
├── skills/cyber-risk-analysis/SKILL.md
├── skills/iec62304-class-a/SKILL.md
├── skills/iec62366-usability/SKILL.md
├── skills/items-store/SKILL.md
├── skills/mitigation-audit/SKILL.md
├── skills/production-risk-analysis/SKILL.md
├── skills/prompts-generator/SKILL.md
├── skills/refresh-items/SKILL.md
├── skills/risk-analysis/SKILL.md
├── skills/risk-report-export/SKILL.md
├── skills/risk-xlsx-export/SKILL.md
├── skills/sdd-export/SKILL.md
├── skills/sds-generate/SKILL.md
├── skills/srs-export/SKILL.md
├── skills/srs-extract/SKILL.md
├── skills/stdr-export/SKILL.md
├── skills/stp-export/SKILL.md
├── skills/str-export/SKILL.md
├── skills/submission-readiness/SKILL.md
├── skills/test-evidence/SKILL.md
├── skills/test-plan/SKILL.md
└── skills/traceability-matrix/SKILL.md

Included Skills22

cyber-risk-analysisskills/cyber-risk-analysis/SKILL.md

IEC 81001-5-1 + AAMI TIR57 + STRIDE reference for the cybersecurity analysis of medical device software, including the four cybersecurity architecture views the FDA 2023 premarket guidance expects and the OTS registry as the supply-chain baseline. Invoke to identify threats, derive controls and produce THR items distinct from safety RSK.

iec62304-class-askills/iec62304-class-a/SKILL.md

Reference for the IEC 62304 class A deliverables, their minimal content and the writing contract that makes them submission-grade (normative vs internal text, kinds, parameters, OTS registry, cybersecurity views, release gate). Invoke whenever an agent generates, updates or reviews 62304 documentation.

iec62366-usabilityskills/iec62366-usability/SKILL.md

IEC 62366-1 reference (usability engineering for medical devices). Invoke to produce Use Scenarios (USC), Use-Related Risks (URSK) and usability test cases (TC type E2E with usability_type), with the same normative-vs-History discipline as the other items.

items-storeskills/items-store/SKILL.md

Local item-per-file store for technical-file items (requirements, design, tests, risks, threats, use scenarios) — the offline equivalent of Matrix Requirements — and the section/frontmatter contract that separates normative, exported text from internal working notes. Invoke before creating, reading or updating any documentation item.

mitigation-auditskills/mitigation-audit/SKILL.md

Convention pour auditer la couverture code-vs-mitigation d'un risque résiduel non-acceptable. À invoquer quand on doit décider si un contrôle proposé en `[TODO]` est en réalité déjà implémenté dans le code, ou pour annoter les SRS de mitigation avec un statut d'implémentation (`absent | partial | implemented`) accompagné d'une evidence code:line.

production-risk-analysisskills/production-risk-analysis/SKILL.md

Référence AAMI TIR57 + IEC 81001-5-1 §6.1 + NIST SP 800-161 pour l'analyse des risques de production / supply chain d'un logiciel médical. À invoquer pour identifier les hazards de packaging / delivery / deployment / update et produire des items PRSK distincts des RSK design (runtime) et des THR cyber (network attacker).

prompts-generatorskills/prompts-generator/SKILL.md

Génère des prompts ready-to-paste à fournir à d'autres sessions Claude Code pour combler les gaps de couverture identifiés par `/doc-build` — code manquant (SRS sans SDS), tests unitaires (SRS sans TC), tests E2E Playwright (SRS surface UI). Un fichier prompt par SRS orphelin sous `docs/generated/prompts/`. À invoquer APRÈS `/doc-build` qui produit `coverage.json` et `_to_implement.md`.

refresh-itemsskills/refresh-items/SKILL.md

Ajoute les champs frontmatter manquants à des items existants après une évolution du schéma (RSK étendu ISO 14971 §C.2 / §7.2 / §7.4 / §7.5 / §7.6, THR étendu CIA triad IEC 81001-5-1, etc.). Mode additif strict — n'écrase JAMAIS le contenu existant ni le corps Markdown.

risk-analysisskills/risk-analysis/SKILL.md

ISO 14971 + IEC 62304 §7 reference for software risk analysis (class A) — hazard identification, control derivation, RSK and PRSK items, and the rule that re-assessments are History, not body text. Invoke to identify hazards, derive controls and produce RSK / PRSK items and mitigation SRS.

risk-report-exportskills/risk-report-export/SKILL.md

Génère le livrable Risk Analysis Report (équivalent annex2-RISK-REPORT.docx d'Avicenna) + une table d'inventaire CSV (équivalent simplifié annex1-RISK-TABLE.xlsx) à partir des items RSK / THR / URSK et de `dt-config.yaml`. À invoquer pour produire `docs/export/<identifier>-<vXX>-RISK-REPORT.md` (+ `.docx` optionnel) après que les items risques sont stables.

risk-xlsx-exportskills/risk-xlsx-export/SKILL.md

Génère le livrable Excel 4-onglets (Design / Production / Usability / Cybersecurity) équivalent du fichier Avicenna `annex1-RISK-TABLE.xlsx` à partir des items RSK / PRSK / URSK / THR et de `dt-config.yaml`. À invoquer pour produire `docs/export/<identifier>-<vXX>-RISK-TABLE.xlsx` (nécessite `openpyxl`).

sdd-exportskills/sdd-export/SKILL.md

Génère le livrable Software Design Description (équivalent du Avicenna `AV-DP-CINA-CSP-10-007-SDD.docx`) — cover signataires, intro, architecture générale, application architecture (rationale + workflows + main software items + software units + class diagram), Security Risk Assessment (depuis THR), et COTS Control. À invoquer pour produire `docs/export/<identifier>-<vXX>-SDD.md` (+ `.docx` optionnel).

sds-generateskills/sds-generate/SKILL.md

Generate Software Design Specification and architecture items (IEC 62304 §5.3-§5.4) from a TS/JS + Python codebase — module items with Design vs Design notes, the OTS registry, and the six required narrative sections of dt-clinical-context.md including the four cybersecurity architecture views. Invoke to produce items in docs/items/SDS/.

srs-exportskills/srs-export/SKILL.md

Génère le livrable SRS habillé pour le dossier technique (cover page signataires, revision history, project references, sections cliniques inlinées, table de traçabilité §3) à partir des items et de `dt-config.yaml`. À invoquer pour produire `docs/export/<identifier>-SRS.md` (+ `.docx` optionnel via pandoc) après que les items SRS / MAP sont stables.

srs-extractskills/srs-extract/SKILL.md

Extract software requirements (IEC 62304 §5.2) from TypeScript/JavaScript and Python code into SRS items — with requirement kinds, declared parameters, numbered criteria and normative-only text. Invoke to generate or enrich items in docs/items/SRS/.

stdr-exportskills/stdr-export/SKILL.md

Génère le livrable STDR (Software Test Description and Reports — équivalent AV-DP-CINA-CSP-10-009-STDR) à partir des items TC/SRS, du fichier test-results.json émis par CI, et de dt-config.yaml. À invoquer pour produire docs/export/<identifier>-<vXX>-STDR.md (+ .docx optionnel) une fois les tests exécutés.

stp-exportskills/stp-export/SKILL.md

Génère le livrable Software Test Plan (STP) habillé pour le dossier technique à partir des TC items et de `dt-config.yaml`. Produit `docs/export/<identifier>-STP.md` (+ `.docx` optionnel). À invoquer après que les items TC sont stables et que `/doc-build` a produit `coverage.json`.

str-exportskills/str-export/SKILL.md

Génère le livrable STR-auto (Software Test Report — automated, équivalent AV-DP-CINA-CSP-10-010-STR-auto) à partir du fichier test-results.json émis par CI et de dt-config.yaml. Format synthétique centré sur la vue pass/fail du run CI. À invoquer après chaque run CI significatif.

submission-readinessskills/submission-readiness/SKILL.md

The release gate for exported deliverables — the document-control check and the submission lint that refuse an SRS, SDD, STP, STD, STR or risk report carrying history, markers, dates, hashes, competitor names or code paths. Invoke before any `--release` export, in `compliance-reviewer`, and whenever a deliverable is about to leave the repository.

test-evidenceskills/test-evidence/SKILL.md

Discover existing tests and formalise them as TC items (IEC 62304 §5.5/§5.7) whose test_id resolves to a real test, whose expected results are numbered and traceable to acceptance criteria, and which never count a planned test as coverage. Invoke to produce docs/items/TC/.

test-planskills/test-plan/SKILL.md

Convention for the Software Test Description (STD, IEEE 829 / IEC 62304 §5.5/§5.7) built from TC items and the hand-maintained narrative in docs/test_plan_intro.md, and for how STP / STDR / STR deliverables consume it. Invoke to generate or understand docs/generated/30_STD.md.

traceability-matrixskills/traceability-matrix/SKILL.md

Build the MAP ↔ SRS ↔ SDS ↔ TC traceability matrix from the frontmatter links and compute coverage, counting only tests that exist. Invoke after SRS/SDS/TC items are created.

Plugin manifests1

plugins/iec62304-writer/.claude-plugin/plugin.json
{
  "name": "iec62304-writer",
  "version": "0.15.0",
  "description": "IEC 62304 class A technical-file pipeline — SRS, SDS, STD, traceability, safety (ISO 14971 §C.2 causal chain + §7.2 control hierarchy + §7.4 quantitative residual + §7.5 cascade), production, cyber (IEC 81001-5-1) and usability (IEC 62366-1 — UEF + Summative Evaluation + IECEE checklist, platform-rich and clinical-narrow modes) risk analyses, incremental update, RAQA-ready exports (SRS + SDD + STP + STDR + STR + Risk Analysis Report + Risk Table xlsx + UEF + USE + UEF-Annex1), and a submission contract (normative vs internal sections, requirement kinds, parameter registry, OTS registry, cybersecurity architecture views) enforced by a gated --release export. Reproduces locally the useful features of Matrix Requirements.",
  "author": {
    "name": "cyrou13"
  },
  "repository": "https://github.com/cyrou13/technical-writer"
}

For maintainers

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[iec62304-writer on Agent Plugins Marketplace](https://pluginsmp.com/plugins/iec62304-writer)