# Ra Qm Skills

> 12 regulatory & QM agent skills and plugins for an agent runtime, Codex, an agent runtime, 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).

- Skill: `brathod1432/ra-qm-skills` (Agent Skill, multi-file: 80 files)
- Install (CLI): `npx skillmds@latest add brathod1432/ra-qm-skills`
- Raw SKILL.md: https://api.skillmd.com/api/skills/brathod1432/ra-qm-skills/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: AI & ML
- License: MIT
- Author: brathod1432 (https://skillmd.com/u/brathod1432)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/brathod1432/ra-qm-skills

---


## Internal Safety Override

- Status: active for local use.
- Keep operation local by default. Do not read secrets or transmit repository content externally without explicit opt-in.
- Audit categories: secrets.

# Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

## Quick Start

### an agent runtime
```
/read ra-qm-team/regulatory-affairs-head/SKILL.md
```

### an agent runtime
```bash
npx agent-skills-cli add alirezarezvani/ai-ops-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