5aaf3e5e0b
Consistent format: '<N> <domain> agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw' Updated both SKILL.md frontmatter and plugin.json for each pack.
67 lines
2.2 KiB
Markdown
67 lines
2.2 KiB
Markdown
---
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name: "ra-qm-skills"
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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)."
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version: 1.0.0
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author: Alireza Rezvani
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license: MIT
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tags:
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- regulatory
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- quality-management
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- iso-13485
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- mdr
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- fda
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- iso-27001
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- gdpr
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agents:
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- claude-code
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- codex-cli
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- openclaw
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---
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# Regulatory Affairs & Quality Management Skills
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12 production-ready compliance skills for HealthTech and MedTech organizations.
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## Quick Start
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### Claude Code
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```
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/read ra-qm-team/regulatory-affairs-head/SKILL.md
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```
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### Codex CLI
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```bash
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npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
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```
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## Skills Overview
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| Skill | Folder | Focus |
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|-------|--------|-------|
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| Regulatory Affairs Head | `regulatory-affairs-head/` | FDA/MDR strategy, submissions |
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| Quality Manager (QMR) | `quality-manager-qmr/` | QMS governance, management review |
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| Quality Manager (ISO 13485) | `quality-manager-qms-iso13485/` | QMS implementation, doc control |
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| Risk Management Specialist | `risk-management-specialist/` | ISO 14971, FMEA, risk files |
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| CAPA Officer | `capa-officer/` | Root cause analysis, corrective actions |
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| Quality Documentation Manager | `quality-documentation-manager/` | Document control, 21 CFR Part 11 |
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| QMS Audit Expert | `qms-audit-expert/` | ISO 13485 internal audits |
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| ISMS Audit Expert | `isms-audit-expert/` | ISO 27001 security audits |
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| Information Security Manager | `information-security-manager-iso27001/` | ISMS implementation |
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| MDR 745 Specialist | `mdr-745-specialist/` | EU MDR classification, CE marking |
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| FDA Consultant | `fda-consultant-specialist/` | 510(k), PMA, QSR compliance |
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| GDPR/DSGVO Expert | `gdpr-dsgvo-expert/` | Privacy compliance, DPIA |
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## Python Tools
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17 scripts, all stdlib-only:
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```bash
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python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
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python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help
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```
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## Rules
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- Load only the specific skill SKILL.md you need
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- Always verify compliance outputs against current regulations
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