ra-qm-skills
alirezarezvani/claude-skills
Router to 15 compliance & quality-management skills for HealthTech/MedTech organizations.
What is ra-qm-skills?
This is a meta-skill that indexes and routes compliance requests to the correct specialized skill within the ra-qm-team plugin. Use it when you have a regulatory or quality-management question but aren't sure which of the 15 bundled skills (ISO 13485, EU MDR, FDA, GDPR, EU AI Act, etc.) to apply.
- Routes compliance requests to the correct specialized skill based on request signals
- Covers 15 regulatory and quality-management domains including ISO 13485 QMS, EU MDR 2017/745, FDA submissions, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, and SOC 2
- Provides a routing table matching request keywords to skill paths and human owners
- Ensures outputs are decision support only, with final determinations routed to named human owners
How to install ra-qm-skills
npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skillsHow to use ra-qm-skills
- 1.Receive or identify a compliance/regulatory request
- 2.Match the request signals (keywords, domain) against the routing table in the skill documentation
- 3.Load the corresponding skill's SKILL.md from ra-qm-team/skills/<skill>/
- 4.If multiple skills match, ask one clarifying question to narrow the selection
- 5.Follow the selected skill's workflow and tools
Use cases
- Determine which skill to use when asked 'prepare us for an ISO 13485 audit'
- Route a question about whether an AI system is high-risk under the EU AI Act
- Identify the correct skill for GDPR data subject rights requests
- Select the appropriate skill for FDA 510(k) submission planning
- Match a risk-analysis or FMEA request to the risk-management-specialist skill
- Regulatory affairs teams in HealthTech/MedTech
- Quality managers and compliance officers
- AI/software teams subject to EU AI Act or ISO 42001
- Organizations managing multiple regulatory frameworks simultaneously
ra-qm-skills FAQ
No. This router ships no tools of its own—it only indexes and directs you to the correct specialized skill, which contains the actual workflows and tools.
Ask one clarifying question to narrow the selection, then route to exactly one skill.
All outputs are decision support only. Final determinations must be routed to the named human owner (QMR, DPO, regulatory counsel, etc.) for that domain.
Verify citations against current regulatory text (e.g., FDA QMSR effective 2026-02-02 replaced legacy QSR subsections). This router does not auto-update.
Full instructions (SKILL.md)
Source of truth, from alirezarezvani/claude-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).
Related skills
More from alirezarezvani/claude-skills and the wider catalog.
red-team
Use when planning or executing authorized red team engagements, attack path analysis, or offensive security simulations. Covers MITRE ATT&CK kill-chain planning, technique scoring, choke point identification, OPSEC risk assessment, and crown jewel targeting.
regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
remember
Explicitly save important knowledge to auto-memory with timestamp and context.
report
Generate test reports with automatic routing to TestRail, Slack, GitHub, or HTML.
research-summarizer
Structured research summarization agent skill for non-dev users. Handles academic papers, web articles, reports, and documentation. Extracts key findings, generates comparative analyses, and produces properly formatted citations. Use when: user wants to summarize a research paper, compare multiple sources, extract citations from documents, or create structured research briefs. Plugin for Claude Code, Codex, Gemini CLI, and OpenClaw.
resume
Resume a paused experiment, read history, and continue iterating from where you left off.