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ra-qm-skills

Orchestrate RA/QM workflows for ISO 13485, MDR, FDA, and GDPR compliance.

1|Updated Mar 18, 2026
Search Tags:#fda#regulatory#gdpr#iso-27001#qm#mdr#iso-13485
One-click install
npx skills add https://github.com/xxih/ai-harness-zh --skill ra-qm-skills-xxih
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: ra-qm-skills
Source: https://github.com/xxih/ai-harness-zh/tree/main/references/translations/alirezarezvani-claude-skills/ra-qm-team
Command: npx skills add https://github.com/xxih/ai-harness-zh --skill ra-qm-skills-xxih

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

RA/QM teams need ready-to-run, production-grade guidance and tooling to manage regulatory compliance, quality systems, risk management, and audits across ISO 13485, MDR, FDA, ISO 27001, GDPR, and related frameworks.

Core Features & Use Cases

  • 12 production-ready skills covering regulatory strategy, QA governance, QMS implementation, CAPA, document control, internal audits, ISMS audits, data privacy compliance, and regulatory intelligence.
  • Python-based tooling and references to standard workflows that automate common RA/QM tasks, accelerating submissions, risk evaluation, and documentation drafting.
  • Use Case: A HealthTech company uses these skills to align their MDR technical documentation, capture CAPA activities, and prepare for ISO 13485 audits within a single cohesive skill set.

Quick Start

Begin by loading ra-qm-skills into Claude Code and run a sample regulatory workflow to validate ISO 13485 and MDR compliance.

Frequently Asked Questions about ra-qm-skills

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I manage ISO 13485 and MDR compliance workflows for HealthTech products?▼

You can manage ISO 13485 and MDR compliance workflows by loading production-ready RA/QM skills that orchestrate regulatory strategy, QMS implementation, and technical documentation drafting for health tech teams.

Can I automate CAPA processes and internal audits using Python-based tooling?▼

Yes, you can automate CAPA processes and internal audits using standard-library Python tools that enforce standards-aligned outputs, accelerating risk evaluation and documentation for ISO 13485 and MDR requirements.

Does this RA/QM skill set support FDA regulatory submissions and GDPR data privacy compliance?▼

This RA/QM skill set supports FDA regulatory submissions and GDPR data privacy compliance by provisioning targeted skills for regulatory intelligence, data privacy governance, and standards-aligned documentation generation.

What is the best way to prepare for an ISO 27001 ISMS audit in a HealthTech environment?▼

The best way to prepare for an ISO 27001 ISMS audit is using orchestrated RA/QM skills that provide ISMS audit guidance, risk management tooling, and document control to ensure safe, compliant operation.

Can I deploy these regulatory and quality management skills with Claude Code or Codex CLI?▼

You can deploy these regulatory and quality management skills with Claude Code, Codex CLI, and OpenClaw, loading the skill set directly into your environment to run sample regulatory workflows and validate compliance.

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