@alirezarezvani/ra-qm-skills
**248 production-ready Claude Code skills, plugins, and agent skills for 11 AI coding tools.**
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SKILL.md
| name | ra-qm-skills |
| description | Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act'). |
| version | 2.9.0 |
| author | Alireza Rezvani |
| license | MIT |
| tags | regulatory, quality-management, iso-13485, mdr, fda, iso-27001, gdpr |
| agents | claude-code, codex-cli, openclaw |
Regulatory Affairs & Quality Management Skills — Router
This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.
Routing table
Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.
| Request signals | Skill | Path |
|---|---|---|
| Regulatory strategy, pathway selection, submissions planning | regulatory-affairs-head | skills/regulatory-affairs-head/ |
| Management review, quality KPIs, QMR governance | quality-manager-qmr | skills/quality-manager-qmr/ |
| ISO 13485 QMS implementation, process control | quality-manager-qms-iso13485 | skills/quality-manager-qms-iso13485/ |
| ISO 14971 risk analysis, FMEA, risk files | risk-management-specialist | skills/risk-management-specialist/ |
| Root cause analysis, corrective/preventive actions | capa-officer | skills/capa-officer/ |
| Document control, 21 CFR Part 11, DHF/DMR/DHR | quality-documentation-manager | skills/quality-documentation-manager/ |
| ISO 13485 internal audits, NC classification | qms-audit-expert | skills/qms-audit-expert/ |
| ISO 27001 audit planning and execution | isms-audit-expert | skills/isms-audit-expert/ |
| ISMS design, security risk assessment | information-security-manager-iso27001 | skills/information-security-manager-iso27001/ |
| EU MDR classification, technical files, PSUR | mdr-745-specialist | skills/mdr-745-specialist/ |
| FDA 510(k)/PMA/De Novo, QMSR | fda-consultant-specialist | skills/fda-consultant-specialist/ |
| GDPR/DSGVO, DPIA, data subject rights | gdpr-dsgvo-expert | skills/gdpr-dsgvo-expert/ |
| EU AI Act risk classification, obligations | eu-ai-act-specialist | skills/eu-ai-act-specialist/ |
| ISO/IEC 42001 AI management system | iso42001-specialist | skills/iso42001-specialist/ |
| SOC 2 Type I/II readiness, trust criteria | soc2-compliance | skills/soc2-compliance/ |
Quick start
# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help
Rules
- Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
- All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
- Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).
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Bill of Materials
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