What regulations does this bundle support?

It supports a wide range of international standards including ISO 13485 (QMS), EU MDR 2017/745, FDA 510(k)/PMA, ISO 27001 (ISMS), ISO 14971 (Risk Management), and GDPR.

Can I load individual skills instead of the whole bundle?

Yes, you can target specific sub-directories to load only the expert skill you need, such as the CAPA Officer or the FDA Consultant.

Does this tool provide legal advice?

No, these skills provide guidance and implementation patterns. You should always verify compliance outputs against the most current official regulations and consult with legal experts.

Is this skill compatible with other CLI tools?

Yes, while optimized for Claude Code, it is also fully compatible with Codex CLI and OpenClaw.

Do I need to install external Python libraries to use the tools?

No, all 17 included Python scripts are built using only the Python standard library to ensure maximum compatibility and security without external dependencies.

Regulatory Affairs & QM Team Bundle

Name: Regulatory Affairs & QM Team Bundle
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

安全与测试

Streamlines compliance for HealthTech and MedTech by providing domain-specific expertise for ISO 13485, EU MDR, FDA submissions, and GDPR.

This comprehensive bundle provides 12 specialized agents designed to navigate the complex landscape of MedTech and HealthTech regulations. It covers essential areas including ISO 13485 Quality Management Systems, EU MDR 2017/745 classification, FDA 510(k) and PMA strategies, and data privacy frameworks like GDPR and ISO 27001. By integrating standard-library Python tools for risk assessment and compliance checking, this skill helps engineering and regulatory teams automate document control, internal audits, and CAPA processes directly within their development environment.

主要功能

01Expert guidance for EU MDR classification and FDA 510(k)/PMA submissions

02Standardized frameworks for ISO 13485 and ISO 27001 internal auditing

030 GitHub stars

04Automated risk matrix calculators and GDPR compliance checkers using Python scripts

05Streamlined document control and CAPA (Corrective and Preventive Action) workflows

0612 specialized roles for RA, QM, Risk Management, and Compliance

使用场景

01Conducting internal audits for ISO 13485 QMS or ISO 27001 ISMS compliance

02Automating risk management files (ISO 14971) and FMEA calculations during product development

03Preparing documentation and strategy for FDA 510(k) or EU MDR CE marking

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 ra-qm-team-bundle

For use in Claude.ai and ChatGPT

主要功能

01Expert guidance for EU MDR classification and FDA 510(k)/PMA submissions

02Standardized frameworks for ISO 13485 and ISO 27001 internal auditing

030 GitHub stars

04Automated risk matrix calculators and GDPR compliance checkers using Python scripts

05Streamlined document control and CAPA (Corrective and Preventive Action) workflows

0612 specialized roles for RA, QM, Risk Management, and Compliance

使用场景

01Conducting internal audits for ISO 13485 QMS or ISO 27001 ISMS compliance

02Automating risk management files (ISO 14971) and FMEA calculations during product development

03Preparing documentation and strategy for FDA 510(k) or EU MDR CE marking

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 ra-qm-team-bundle

For use in Claude.ai and ChatGPT