Skip to main content
affpapa.org
RU EN
skill Claude Code

ra-qm-skills — Claude Code skill: what it does, how to install

Routes regulatory and quality management queries to 15 specialised skills in the ra-qm-team bundle. Useful when a compliance task does not immediately match a single standard.

Install into Claude Code · Plugin marketplace All methods and platforms ↓ 
/plugin marketplace add alirezarezvani/claude-skills
/plugin install ra-qm-skills@claude-code-skills
Open on GitHub

What ra-qm-skills does

This skill acts as a router across 15 compliance disciplines for HealthTech and MedTech teams. When you describe a regulatory goal, the router checks its routing table and opens ra-qm-team/skills//SKILL.md. If your prompt fits several paths, the assistant pauses to ask one clarifying question before moving forward.

The router carries no tools of its own. It directs requests toward dedicated skills covering ISO 13485, EU MDR, FDA QMSR submissions, ISO 14971 risk files, or the EU AI Act. Every output functions strictly as decision support. Final compliance calls must stay with designated human roles such as the QMR, DPO, or legal counsel.

Install this skill if you use the full alirezarezvani/claude-skills suite and want Claude to triage broad audit questions automatically. If you only care about a single regulation like SOC 2, you are better off loading that individual skill directly.

What it helps with

  • route ambiguous compliance queries to the correct regulatory workflow
  • navigate requirements across FDA QMSR, EU MDR, and ISO 13485
  • determine the applicable risk classification under the EU AI Act
  • locate relevant audit checklists and scripts in the ra-qm-team package

Example prompts for the agent

  • Prepare our team for an upcoming ISO 13485 surveillance audit
  • Check whether our clinical AI system is high-risk under the EU AI Act
  • Help us plan a root cause analysis for an open CAPA report

How to install ra-qm-skills

1Plugin marketplace

/plugin marketplace add alirezarezvani/claude-skills
/plugin install ra-qm-skills@claude-code-skills

This installs the whole ra-qm-skills plugin with all its skills

2Skills CLI (Vercel)

npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a claude-code

3Manually: put the files in place

~/.claude/skills/ra-qm-skills/SKILL.md

Copy the whole skill folder; for one project use .claude/skills/ra-qm-skills/

From the same set349

The whole set →
engineering-skills Alireza Rezvani An engineering skill index for Claude Code that helps you select one specialist SKILL.md for the task at hand. It covers architecture, testing, DevOps, and data work. Claude Code 2,387installs finance-skills Alireza Rezvani Routes ambiguous finance prompts to the right bundled skill: financial-analyst, saas-metrics-coach, or month-end-close. Claude Code 2,312installs marketing-skills Alireza Rezvani A directory and router for marketing skills in Claude Code. It picks the right specialist skill for SEO, content, CRO, channels, and related tasks. Claude Code 2,264installs business-growth-skills Alireza Rezvani Routes growth and revenue prompts to the right specialized skill across customer success, sales engineering, RevOps, and proposals in Claude Code. Claude Code 2,189installs engineering-advanced-skills Alireza Rezvani An index of 37 engineering skills for architecture, automation, reliability, and platform work. Use it when a project needs task-specific engineering workflows. Claude Code 2,019installs product-skills Alireza Rezvani Product work orchestrator for Claude Code. Routes queries across 16 domain lanes and validates discovery trees with deterministic scripts. Claude Code 1,994installs pm-skills Alireza Rezvani Routes project-delivery requests across 8 PM sub-skills for Jira, Confluence, sprints, reporting, and team communication. Useful for controlled delivery work. Claude Code 1,975installs senior-backend Alireza Rezvani Scaffolds backend APIs, detects database bottlenecks, and runs load tests. Useful when designing Express routes, optimizing PostgreSQL, or preparing for production. Claude Code 1,674installs

Similar

salesforce-component-standards official github Guides Salesforce UI development across LWC, Aura, and Visualforce. Enforces SLDS 2 compliance, accessibility, and platform security. GitHub Copilot 770installs assuredworkloads-environment-assessor official google Evaluates Google Cloud resources and Org Policies against data sovereignty standards. Recommends the right Assured Workloads framework before rollout. Claude Code Gemini CLI CX Codex 475installs api-gateway-backend-security-and-rate-limiting official google Configure client authentication, backend access, and per-project quotas for Google Cloud API Gateway. Use it when securing Cloud Run services or investigating quota errors. Claude Code Gemini CLI CX Codex 360installs git-guardrails-claude-code Matt Pocock This skill adds a Claude Code hook that stops risky Git commands before they run. Use it when an agent must not push or discard working-tree changes. Claude Code 499,069installs ponytail-review DietrichGebert ponytail-review reviews a change beyond the diff, checking connected code, bugs, risks, load, tests, speed, and unnecessary code. Use it for PRs and commits. Claude Code CX Codex Cursor +1 56,300installs ponytail-audit DietrichGebert It audits a repository and ranks bugs, risks, and redundant code in a one-shot report. Use it when you need a review without code changes. Claude Code CX Codex Cursor +1 44,800installs security-audit cloudflare Reviews codebases and APIs for vulnerabilities using safe sandboxing. Fits pre-release security reviews, pen-test triage, and architecture checks. Claude Code CX Codex Cursor +1 52,200installs security-and-hardening addyosmani Guides threat modeling and security checks for code that handles user input, authentication, sessions, or external services. Use it when building a feature that accepts untrusted data or reviewing code before release. Claude Code CX Codex Cursor +1 69,400installs

Questions about ra-qm-skills

How do I install ra-qm-skills in Claude Code?

Add the repository via /plugin marketplace add alirezarezvani/claude-skills, then install the skill with /plugin install ra-qm-skills@claude-code-skills. You can also run npx skills add alirezarezvani/claude-skills --skill ra-qm-skills -a claude-code.

What does ra-qm-skills do?

It acts as an index for 15 HealthTech compliance skills. It parses your prompt against a routing table and opens the appropriate SKILL.md file, asking a clarifying question if multiple standards apply.

Does ra-qm-skills make final regulatory decisions?

No. The skill rules require all outputs to serve as decision support only. Definitive regulatory conclusions must route to human owners like your QMR, DPO, or regulatory counsel.

Source text

SKILL.md · MIT 
---
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')."
license: MIT
metadata:
  version: 2.9.0
  author: Alireza Rezvani
  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

```bash
# 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).

© Alireza Rezvani · MIT · alirezarezvani/claude-skills

See also

Project sponsors

Companies that keep this analytics open
Gold sponsor
Nutra.Club

Impressions, clicks and code copies — open statistics. We keep the numbers public for the same reason NeBlask itself is public. Become a sponsor