alirezarezvani/ra-qm-skills
ra-qm-team/skills/ra-qm-skills/SKILL.md
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').
$ install --global
skillsauthnpx skillsauth add alirezarezvani/claude-skills ra-qm-skillsInstall this skill globally with one command. Works with Claude Code, Cursor, and Windsurf.
Security Scan Results
3 of 9 scanners reported clean
Some scanners were skipped, did not run, or reported a non-clean status. Review each row below.
3
Scanners Passed
9
Scanners in report
Clean
TrivyContainer and dependency vulnerability scanner
95%
Clean
SemgrepStatic code analysis for vulnerabilities
95%
Clean
mcp-scan (Snyk)Model Context Protocol security validation
95%
Skipped
Snyk (dep)Open source security scanning
50%
Skipped
Socket.devSupply chain security analysis
50%
Skipped
VirusTotalMulti-engine malware detection
50%
Skipped
CrowdStrikeAdvanced threat intelligence
50%
Skipped
OSV-ScannerOpen Source Vulnerability database check
50%
Skipped
OWASP Dep-Check
50%
Last scanned: Jul 7, 2026, 3:46 AM174.5s1 file scanned
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
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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