ra-qm-skills
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').
Profile →npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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-exp
- Routing table
- Quick start
- Rules
cat ra-qm-team/skills/risk-management-specialist/SKILL.md python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help
What does the ra-qm-skills skill do?
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').
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill ra-qm-skills --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.