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).
- License 许可
- MIT
- 最近更新
- 2026-04-03
- Stars
- ★ 1
- Forks
- 1
01 前言 Front Matter
- name
- ra-qm-skills
- tags
- [ "regulatory", "quality-management", "iso-13485", "mdr", "fda", "iso-27001", "gdpr" ]
- agents
- [ "claude-code", "codex-cli", "openclaw" ]
- author
- Alireza Rezvani
- license
- MIT
- version
- 1.0.0
- 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), CAPA, document control, auditing. Python tools (stdlib-only).
02 资源文件 17
- 参考文档.claude-plugin/plugin.json640 B
- 参考文档.codex/instructions.md1.3 KB
- 资产文件capa-officer.zip4.7 KB
- 参考文档CLAUDE.md4.4 KB
- 资产文件fda-consultant-specialist.zip5.5 KB
- 参考文档final-complete-skills-collection.md8.6 KB
- 资产文件gdpr-dsgvo-expert.zip5.8 KB
- 资产文件information-security-manager-iso27001.zip5.7 KB
- 资产文件isms-audit-expert.zip5.5 KB
- 资产文件mdr-745-specialist.zip4.9 KB
- 资产文件qms-audit-expert.zip5.4 KB
- 资产文件quality-documentation-manager.zip5.8 KB
- 资产文件quality-manager-qmr.zip4.9 KB
- 资产文件quality-manager-qms-iso13485.zip4.6 KB
- 参考文档README.md32.3 KB
- 资产文件regulatory-affairs-head.zip8.2 KB
- 资产文件risk-management-specialist.zip5.2 KB
03 SKILL.md 正文
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
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