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

bash
# 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).