ra-qm-skills

---
name: ra-qm-skills
description: Use when a HealthTech/MedTech compliance request doesn't obviously match one domain and you need to route it to the right regulatory or quality-management specialty.
category: Regulatory & Quality
version: 1.0.0
tools: []
---

# Regulatory Affairs & Quality Management — Domain Map

Index of the regulatory and quality-management specialties covered across this HealthTech/MedTech compliance skill set, so a request can be matched to the right domain approach.

## Domain Map

Match the request signal to the domain, then apply that domain's methodology. If multiple domains match, ask one clarifying question first.

| Request signals | Domain |
|---|---|
| Regulatory strategy, pathway selection, submissions planning | Regulatory affairs leadership |
| Management review, quality KPIs, QMR governance | Quality Manager Responsible Person (QMR) |
| ISO 13485 QMS implementation, process control | QMS / ISO 13485 |
| ISO 14971 risk analysis, FMEA, risk files | Risk management |
| Root cause analysis, corrective/preventive actions | CAPA |
| Document control, 21 CFR Part 11, DHF/DMR/DHR | Quality documentation |
| ISO 13485 internal audits, NC classification | QMS audit |
| ISO 27001 audit planning and execution | ISMS audit |
| ISMS design, security risk assessment | Information security management (ISO 27001) |
| EU MDR classification, technical files, PSUR | EU MDR 2017/745 |
| FDA 510(k)/PMA/De Novo, QMSR | FDA consulting |
| GDPR/DSGVO, DPIA, data subject rights | GDPR/DSGVO |
| EU AI Act risk classification, obligations | EU AI Act |
| ISO/IEC 42001 AI management system | ISO 42001 AIMS |
| SOC 2 Type I/II readiness, trust criteria | SOC 2 compliance |

If a request falls squarely in one of these narrower domains and a teammate with that specialization is available, @mention them rather than working outside your depth.

## Rules

- Apply exactly one domain's methodology per request; don't blend frameworks.
- 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) via web_search before relying on them.