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).
Source: alirezarezvani/claude-skills → ra-qm-team/skills/ra-qm-skills/SKILL.md
1---2name: ra-qm-skills3description: 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').4---567# Regulatory Affairs & Quality Management Skills — Router89This 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.1011## Routing table1213Match the request, then load `ra-qm-team/skills/<skill>/SKILL.md`. If multiple rows match, ask one clarifying question first.1415| Request signals | Skill | Path |16|---|---|---|17| Regulatory strategy, pathway selection, submissions planning | regulatory-affairs-head | `skills/regulatory-affairs-head/` |18| Management review, quality KPIs, QMR governance | quality-manager-qmr | `skills/quality-manager-qmr/` |19| ISO 13485 QMS implementation, process control | quality-manager-qms-iso13485 | `skills/quality-manager-qms-iso13485/` |20| ISO 14971 risk analysis, FMEA, risk files | risk-management-specialist | `skills/risk-management-specialist/` |21| Root cause analysis, corrective/preventive actions | capa-officer | `skills/capa-officer/` |22| Document control, 21 CFR Part 11, DHF/DMR/DHR | quality-documentation-manager | `skills/quality-documentation-manager/` |23| ISO 13485 internal audits, NC classification | qms-audit-expert | `skills/qms-audit-expert/` |24| ISO 27001 audit planning and execution | isms-audit-expert | `skills/isms-audit-expert/` |25| ISMS design, security risk assessment | information-security-manager-iso27001 | `skills/information-security-manager-iso27001/` |26| EU MDR classification, technical files, PSUR | mdr-745-specialist | `skills/mdr-745-specialist/` |27| FDA 510(k)/PMA/De Novo, QMSR | fda-consultant-specialist | `skills/fda-consultant-specialist/` |28| GDPR/DSGVO, DPIA, data subject rights | gdpr-dsgvo-expert | `skills/gdpr-dsgvo-expert/` |29| EU AI Act risk classification, obligations | eu-ai-act-specialist | `skills/eu-ai-act-specialist/` |30| ISO/IEC 42001 AI management system | iso42001-specialist | `skills/iso42001-specialist/` |31| SOC 2 Type I/II readiness, trust criteria | soc2-compliance | `skills/soc2-compliance/` |3233## Quick start3435```bash36# Example: route a risk-analysis request37cat ra-qm-team/skills/risk-management-specialist/SKILL.md38python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help39```4041## Rules4243- Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.44- All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.45- Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).4647---4849**Source:** [`alirezarezvani/claude-skills`](https://github.com/alirezarezvani/claude-skills) → `ra-qm-team/skills/ra-qm-skills/SKILL.md`
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