★ Featured Testing & Quality

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...

AuthorAlireza Rezvani

Version2.9.0

LicenseMIT

Token count~563

UpdatedJun 4, 2026

Install

Quick install

via npx skills · works with 57+ agents

npx skills add https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/ra-qm-skills

Or pick agent:

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent claude-code

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent cursor

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent codex

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent opencode

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent github-copilot

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent windsurf

More install options

Shorthand — useful for multi-skill repos:

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills

Manual — clone the repo and drop the folder into your agent's skills directory:

git clone https://github.com/alirezarezvani/claude-skills.git

cp -r claude-skills/ra-qm-team/skills/ra-qm-skills ~/.claude/skills/

How to use: Once installed, ask your agent to "use the ra-qm-skills skill" or describe what you want (e.g. "12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI,"). Requires Node.js 18+.

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

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:

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

SKILL.md source

---
name: ra-qm-skills
description: 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...
---

# 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

Testing & Quality