Is GDPR compliance covered for healthcare data?

Yes, the suite includes a GDPR/DSGVO expert skill specifically for privacy compliance, DPIA assessments, and automated compliance checking.

Does this skill support ISO 13485 implementation?

Yes, it includes specialized agent skills for Quality Managers to govern, document, and implement ISO 13485 Quality Management Systems.

What coding agents are compatible with these skills?

These skills are optimized for Claude Code, Codex CLI, and OpenClaw, providing domain-specific guidance across various AI coding environments.

Can it help with FDA 510(k) submissions?

Absolutely; the FDA Consultant and Regulatory Affairs Head skills are specifically designed to provide guidance on 510(k), PMA, and QSR compliance strategies.

Does it include tools for medical device risk management?

Yes, it features an ISO 14971-aligned Risk Management Specialist skill along with Python scripts for calculating risk matrices and FMEA files.

Regulatory & Quality Management Team

Name: Regulatory & Quality Management Team
Author: alirezarezvani

byalirezarezvani

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9,958

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セキュリティとテスト

Automates and manages complex regulatory compliance and quality management workflows for HealthTech and MedTech organizations.

This comprehensive suite provides 12 specialized agent skills designed to navigate the rigorous requirements of global health regulations and quality standards. From drafting FDA 510(k) submissions and managing ISO 13485 quality systems to conducting GDPR privacy impact assessments and ISO 27001 security audits, these tools empower development teams to build compliant software-as-a-medical-device (SaMD) and digital health solutions. It includes built-in Python tools for risk matrix calculations and compliance checking, making it an essential toolkit for engineering and compliance teams operating in highly regulated industries.

主な機能

0112 specialized compliance roles including RA Head, Quality Manager, and GDPR Expert

02Integrated Python-based compliance checkers and risk matrix calculators

03Comprehensive ISMS and GDPR audit frameworks for data security and privacy

049,958 GitHub stars

05Automated risk management tools following ISO 14971 and FMEA principles

06Deep support for international standards like ISO 13485, MDR, and FDA 510(k)

ユースケース

01Automating CAPA (Corrective and Preventive Action) workflows and root cause analysis

02Implementing a 21 CFR Part 11 compliant document control system for digital health products

03Preparing technical documentation and strategy for CE marking under EU MDR 2017/745

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add alirezarezvani/claude-skills ra-qm-team-main

For use in Claude.ai and ChatGPT

主な機能

0112 specialized compliance roles including RA Head, Quality Manager, and GDPR Expert

02Integrated Python-based compliance checkers and risk matrix calculators

03Comprehensive ISMS and GDPR audit frameworks for data security and privacy

049,958 GitHub stars

05Automated risk management tools following ISO 14971 and FMEA principles

06Deep support for international standards like ISO 13485, MDR, and FDA 510(k)

ユースケース

01Automating CAPA (Corrective and Preventive Action) workflows and root cause analysis

02Implementing a 21 CFR Part 11 compliant document control system for digital health products

03Preparing technical documentation and strategy for CE marking under EU MDR 2017/745