ra-qm-skills
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
Best use case
ra-qm-skills is best used when you need a repeatable AI agent workflow instead of a one-off prompt.
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
Teams using ra-qm-skills should expect a more consistent output, faster repeated execution, less prompt rewriting.
When to use this skill
- You want a reusable workflow that can be run more than once with consistent structure.
When not to use this skill
- You only need a quick one-off answer and do not need a reusable workflow.
- You cannot install or maintain the underlying files, dependencies, or repository context.
Installation
Claude Code / Cursor / Codex
Manual Installation
- Download SKILL.md from GitHub
- Place it in
.claude/skills/ra-qm-team/SKILL.mdinside your project - Restart your AI agent — it will auto-discover the skill
How ra-qm-skills Compares
| Feature / Agent | ra-qm-skills | Standard Approach |
|---|---|---|
| Platform Support | Not specified | Limited / Varies |
| Context Awareness | High | Baseline |
| Installation Complexity | Unknown | N/A |
Frequently Asked Questions
What does this skill do?
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
Where can I find the source code?
You can find the source code on GitHub using the link provided at the top of the page.
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SKILL.md Source
# Regulatory Affairs & Quality Management Skills 12 production-ready compliance skills for HealthTech and MedTech organizations. ## Quick Start ### Claude Code ``` /read ra-qm-team/regulatory-affairs-head/SKILL.md ``` ### Codex CLI ```bash npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team ``` ## Skills Overview | Skill | Folder | Focus | |-------|--------|-------| | Regulatory Affairs Head | `regulatory-affairs-head/` | FDA/MDR strategy, submissions | | Quality Manager (QMR) | `quality-manager-qmr/` | QMS governance, management review | | Quality Manager (ISO 13485) | `quality-manager-qms-iso13485/` | QMS implementation, doc control | | Risk Management Specialist | `risk-management-specialist/` | ISO 14971, FMEA, risk files | | CAPA Officer | `capa-officer/` | Root cause analysis, corrective actions | | Quality Documentation Manager | `quality-documentation-manager/` | Document control, 21 CFR Part 11 | | QMS Audit Expert | `qms-audit-expert/` | ISO 13485 internal audits | | ISMS Audit Expert | `isms-audit-expert/` | ISO 27001 security audits | | Information Security Manager | `information-security-manager-iso27001/` | ISMS implementation | | MDR 745 Specialist | `mdr-745-specialist/` | EU MDR classification, CE marking | | FDA Consultant | `fda-consultant-specialist/` | 510(k), PMA, QSR compliance | | GDPR/DSGVO Expert | `gdpr-dsgvo-expert/` | Privacy compliance, DPIA | ## Python Tools 17 scripts, all stdlib-only: ```bash python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help ``` ## Rules - Load only the specific skill SKILL.md you need - Always verify compliance outputs against current regulations
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wiki-query
Query the LLM Wiki — reads index.md first, drills into 3-10 relevant pages, synthesizes an answer with inline [[wikilink]] citations, and offers to file the answer back as a new comparison or synthesis page. Usage /wiki-query "<question>"
wiki-log
Show recent entries from the LLM Wiki log (wiki/log.md). Uses the standardized
wiki-lint
Run a health check on the LLM Wiki vault — mechanical checks (orphans, broken links, stale pages, missing frontmatter, log gap, duplicates) plus semantic checks (contradictions, cross-reference gaps, concepts missing their own page). Outputs a markdown report with suggested actions. Usage /wiki-lint [--stale-days N] [--log-gap-days N]
wiki-init
Bootstrap a fresh LLM Wiki vault with the three-layer structure, schema files, and starter templates. Usage /wiki-init <path> --topic "<topic>" [--tool all|claude-code|codex|cursor|antigravity]
wiki-ingest
Ingest a source file from raw/ into the LLM Wiki — read, discuss, write summary page, update cross-references across 5-15 pages, regenerate index, append to log. Usage /wiki-ingest <path-to-source>