| name | ra-qm-skills |
| description | "Use — 12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485" |
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
Diff History
- v00.33.0: Ingested from claude-skills-main
Why This Skill Exists
Use — 12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485
When to Use
Use this skill when the task requires ra qm skills capabilities.
What If Fails
- condition: Modelo de ML indisponível ou não carregado
