Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.
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').
Review the instructions the agent will receive before you install.
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.
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/ |
# 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
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