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ra-qm-skills

Provide regulatory compliance and quality management guidance for HealthTech and MedTech.

Updated Mar 12, 2026
Search Tags:#quality management#fda#iso 13485#eu mdr#regulatory affairs#medtech#healthtech
One-click install
npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill ra-qm-skills-fantasia1999
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: ra-qm-skills
Source: https://github.com/Fantasia1999/claude-skills-zh/tree/main/translations/ra-qm-team
Command: npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill ra-qm-skills-fantasia1999

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This comprehensive Skill set addresses the complex and ever-evolving regulatory and quality management challenges faced by HealthTech and MedTech companies, ensuring compliance and accelerating market access.

Core Features & Use Cases

  • End-to-End Compliance: Covers the full spectrum from strategic regulatory planning and FDA/EU submissions to QMS implementation (ISO 13485), risk management (ISO 14971), cybersecurity (ISO 27001), and data privacy (GDPR).
  • Expert Guidance & Automation: Provides detailed guidance through SKILL.md files and automates critical tasks with Python scripts for compliance checks, reporting, and analysis.
  • Use Case: A startup developing a new AI-powered diagnostic device can use this Skill to define its regulatory pathway for both the US (FDA 510(k)) and EU (MDR Class IIb), implement an ISO 13485 QMS, conduct a thorough risk assessment, and prepare the necessary technical documentation and clinical evaluation reports.

Quick Start

Use the ra-qm-skills to generate a regulatory strategy for a new AI diagnostic device targeting the US and EU markets.

Frequently Asked Questions about ra-qm-skills

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

FAQPage Schema
How do I prepare an FDA 510(k) submission for a new diagnostic device?▼

To prepare an FDA 510(k) submission, you must define a regulatory strategy, conduct risk management per ISO 14971, and compile technical documentation. This Skill provides expert guidance and automated tools to streamline 510(k) preparation and compliance tracking.

What is the regulatory pathway for an AI diagnostic device under EU MDR 2017/745?▼

The EU MDR regulatory pathway for an AI diagnostic device requires classifying the device, fulfilling clinical evaluation requirements, and implementing a compliant QMS. This Skill helps navigate MDR Class IIb requirements and generate necessary technical documentation.

Can I automate CAPA and document control processes for healthtech compliance?▼

You can automate CAPA and document control using Python tools integrated with compliance frameworks like Claude Code and OpenClaw agents. This Skill includes scripts to automate critical tasks for compliance checks, reporting, and analysis.

Does this regulatory affairs suite cover GDPR and ISO 27001 cybersecurity compliance?▼

This regulatory affairs suite covers GDPR/DSGVO data privacy compliance and ISO 27001 ISMS cybersecurity requirements. It provides expert guidance to address data privacy and cybersecurity challenges for HealthTech and MedTech companies.

What is the best way to conduct internal audits for ISO 13485 and MDR compliance?▼

The best way to conduct internal audits for ISO 13485 and MDR compliance is to follow structured procedures supported by automated reporting tools. This Skill offers detailed audit guidance and Python scripts to ensure thorough quality management reviews.

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