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').
RA/QM Skills is a router (index) skill for a plugin bundling fifteen regulatory-affairs and quality-management skills aimed at HealthTech and MedTech organizations. It solves the problem of skill selection: when a compliance request does not clearly map to one specialized skill, this router matches the request signals to the correct downstream skill and loads that skill's SKILL.md. The covered domains include ISO 13485 quality management systems, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk analysis, CAPA, document control and 21 CFR Part 11, ISO 27001/ISMS, ISO 42001 AI management systems, the EU AI Act, GDPR/DSGVO, SOC 2, and auditing.
The skill is a single SKILL.md containing a routing table that maps request signals (for example, "ISO 14971 risk analysis" or "is my AI system high-risk under the AI Act") to a target skill and path. If several rows match it asks one clarifying question, then routes to exactly one skill. It ships no tools of its own beyond a documented example of catting a downstream SKILL.md and invoking a downstream risk-matrix helper. Two governance rules stand out: all outputs are framed as decision support that routes final compliance determinations to a named human owner (QMR, DPO, regulatory counsel) rather than auto-deciding, and it instructs verification of regulatory citations against current text, noting the FDA QMSR became effective in 2026.
Target users are regulatory-affairs professionals, quality managers, and compliance teams in medical-device and health-tech companies who need to quickly reach the right compliance workflow. Use cases include preparing for an ISO 13485 audit, classifying a device under EU MDR, or determining AI Act risk category.
It is a router/index. It matches a compliance request to one of fifteen bundled regulatory and quality-management skills and loads that skill's SKILL.md; it ships no compliance tooling of its own.
ISO 13485, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control and 21 CFR Part 11, ISO 27001/ISMS, ISO 42001, the EU AI Act, GDPR/DSGVO, SOC 2, and auditing.
No. All outputs are decision support only; final determinations route to a named human owner such as the QMR, DPO, or regulatory counsel. It never auto-decides.
It asks one clarifying question first, then routes to exactly one skill and follows that skill's workflow.
Quick Setup:
.claude/skills/Repository
alirezarezvani/claude-skills