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)."
Resources
18Install
npx skillscat add alirezarezvani/claude-skills/ra-qm-skills Install via the SkillsCat registry.
SKILL.md
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.mdCodex CLI
npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-teamSkills 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 --helpRules
- Load only the specific skill SKILL.md you need
- Always verify compliance outputs against current regulations