What regulations does this skill bundle cover?

The bundle covers global standards including ISO 13485 (QMS), EU MDR 2017/745, FDA 510(k)/PMA, ISO 27001 (Security), and GDPR/DSGVO (Privacy).

Does it include tools for risk management?

Yes, it provides a Risk Management Specialist agent and Python scripts for calculating risk matrices and managing FMEA according to ISO 14971.

Is this skill compatible with my current AI agent?

The skills are optimized for Claude Code, Codex CLI, and OpenClaw, but the patterns can be used across any AI agent that supports custom instructions.

Can I use these agents for internal audits?

Yes, it includes specialized QMS and ISMS Audit Expert agents designed to facilitate internal audits with structured checklists and compliance verification.

Regulatory & Quality Management Bundle

Name: Regulatory & Quality Management Bundle
Author: alirezarezvani

byalirezarezvani

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9,958

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安全与测试

Streamlines HealthTech compliance by providing 12 specialized agents for ISO 13485, FDA, MDR, and GDPR standards.

This comprehensive bundle equips development teams with a suite of 12 AI-powered agents specialized in the high-stakes world of MedTech and HealthTech regulatory compliance. It provides expert guidance for navigating complex frameworks including ISO 13485 Quality Management Systems, EU MDR 2017/745, and FDA 510(k) submissions, while also covering security standards like ISO 27001 and GDPR. By integrating these skills into Claude Code, teams can automate the creation of risk management files (ISO 14971), manage CAPA workflows, conduct internal audits, and maintain 21 CFR Part 11 compliant document control, ensuring that regulatory requirements are built into the development process from the start.

主要功能

01Support for global MedTech standards: ISO 13485, FDA 510(k)/PMA, and EU MDR.

02Integrated risk management tools including ISO 14971 risk matrix calculators.

03Automated workflows for CAPA root cause analysis and corrective actions.

0412 specialized agent roles covering Regulatory Affairs, QM, and Security.

059,958 GitHub stars

06Pre-configured audit checklists for QMS and ISMS compliance reviews.

使用场景

01Conducting internal audits and Gap Analysis for ISO 13485 or ISO 27001 certification.

02Drafting documentation for FDA 510(k) submissions and CE marking under EU MDR.

03Performing Data Protection Impact Assessments (DPIA) for GDPR compliance in healthcare apps.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

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

For use in Claude.ai and ChatGPT

主要功能

01Support for global MedTech standards: ISO 13485, FDA 510(k)/PMA, and EU MDR.

02Integrated risk management tools including ISO 14971 risk matrix calculators.

03Automated workflows for CAPA root cause analysis and corrective actions.

0412 specialized agent roles covering Regulatory Affairs, QM, and Security.

059,958 GitHub stars

06Pre-configured audit checklists for QMS and ISMS compliance reviews.

使用场景

01Conducting internal audits and Gap Analysis for ISO 13485 or ISO 27001 certification.

02Drafting documentation for FDA 510(k) submissions and CE marking under EU MDR.

03Performing Data Protection Impact Assessments (DPIA) for GDPR compliance in healthcare apps.