ra-qm-skills

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
tags	["regulatory","quality-management","iso-13485","mdr","fda","iso-27001","gdpr"]
agents	["claude-code","codex-cli","openclaw"]

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).