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ra-qm-skills

Automate HealthTech compliance tasks across ISO 13485, EU MDR, and FDA submissions.

2|Updated Mar 13, 2026
Search Tags:#compliance#quality management#fda#iso 13485#regulatory affairs#mdr
One-click install
npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill ra-qm-skills
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: ra-qm-skills
Source: https://github.com/zhangzhang-111-i/claude-skills111/tree/main/ra-qm-team
Command: npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill ra-qm-skills

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Navigating the complex landscape of HealthTech and MedTech regulations (ISO 13485, MDR, FDA, etc.) is challenging and time-consuming. This Skill collection provides expert guidance and automation tools to ensure compliance, accelerate market access, and maintain quality standards.

Core Features & Use Cases

  • End-to-End Compliance: Covers all major regulatory frameworks from QMS implementation to post-market surveillance.
  • Automated Workflows: Utilizes Python scripts for tasks like risk analysis, compliance checking, and audit scheduling.
  • Use Case: A startup developing a new medical device can use the regulatory-affairs-head skill to plan its FDA submission strategy, then leverage the risk-management-specialist skill to perform an FMEA analysis, and finally use the quality-manager-qms-iso13485 skill to ensure their QMS meets ISO 13485 requirements.

Quick Start

Use the regulatory-affairs-head skill to plan the FDA submission strategy for a new medical device.

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 strategy for a new medical device?▼

To prepare an FDA 510(k) submission strategy, you can use the regulatory-affairs-head skill to plan your approach, then apply the risk-management-specialist skill for FMEA analysis to ensure compliance and accelerate market access.

How do I implement an ISO 13485 quality management system for HealthTech?▼

Implementing an ISO 13485 quality management system involves using the quality-manager-qms-iso13485 skill to verify your QMS meets regulatory requirements, supported by automated Python workflows for compliance checking and audit scheduling.

Can I automate risk analysis and FMEA for ISO 14971 compliance?▼

Yes, you can automate risk analysis for ISO 14971 compliance. The suite includes Python automation scripts designed to execute risk management tasks, perform FMEA analysis, and streamline your overall regulatory workflow.

Does this cover EU MDR 2017/745 and GDPR compliance for medical devices?▼

Yes, this covers EU MDR 2017/745 and GDPR/DSGVO compliance. It provides specialized reference guides and automated tools to help navigate these specific regulatory frameworks alongside ISO 27001 ISMS requirements.

What is the best way to manage CAPA and post-market surveillance audits?▼

The best way to manage CAPA and audits is by leveraging the specialized quality management skills and Python automation tools, which provide detailed reference guides for post-market surveillance and automate audit scheduling tasks.

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