How do I load a specific regulatory skill in Claude Code?

You can load a specific module by using the /read command followed by the path to the sub-skill, for example: /read ra-qm-team/regulatory-affairs-head/SKILL.md.

Can this skill help with CAPA management?

Yes, it includes a dedicated CAPA Officer module designed specifically for root cause analysis and corrective/preventive action planning.

What standards does the RA-QM team skill cover?

It covers ISO 13485, EU MDR 2017/745, FDA 510(k)/PMA, ISO 27001, GDPR/DSGVO, and ISO 14971 risk management.

Do I need external dependencies for the included Python tools?

No, all 17 included scripts are built using the Python standard library (stdlib-only) for maximum portability and security.

Is this skill suitable for medical device software (SaMD) development?

Yes, it is specifically designed to support the documentation and quality requirements inherent in SaMD and other regulated medical software projects.

HealthTech Regulatory & Quality Management (RA-QM)

Name: HealthTech Regulatory & Quality Management (RA-QM)
Author: zhangzhang-111-i

byzhangzhang-111-i

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安全与测试

Provides a comprehensive suite of 12 production-ready skills for HealthTech and MedTech organizations to manage regulatory compliance and quality assurance.

The ra-qm-team skill pack is a specialized toolkit designed for Claude Code to assist HealthTech and MedTech companies in navigating complex regulatory landscapes like FDA 510(k), EU MDR, ISO 13485, and GDPR. It offers deep domain expertise in quality management systems (QMS), risk management (ISO 14971), and information security (ISO 27001), enabling teams to automate compliance documentation, perform root cause analysis for CAPAs, and streamline internal audits through integrated Python tools. This suite is essential for developers and quality managers who need to maintain rigorous documentation and safety standards while accelerating their development lifecycle.

主要功能

010 GitHub stars

02Detailed guidance for Information Security Management Systems (ISO 27001)

03Automated support for document control and 21 CFR Part 11 compliance

04Specialized modules for Risk Management (ISO 14971) and CAPA reporting

05Integrated Python tools for risk matrix calculations and GDPR compliance checks

06Comprehensive regulatory coverage including FDA, EU MDR, and ISO 13485

使用场景

01Conducting internal ISO 13485 or ISO 27001 quality and security audits

02Preparing documentation for FDA 510(k) or PMA submissions

03Managing risk files and FMEA processes for medical device software

What are Skills?·How to Install

Install with 🐟 Skill.Fish

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

For use in Claude.ai and ChatGPT

主要功能

010 GitHub stars

02Detailed guidance for Information Security Management Systems (ISO 27001)

03Automated support for document control and 21 CFR Part 11 compliance

04Specialized modules for Risk Management (ISO 14971) and CAPA reporting

05Integrated Python tools for risk matrix calculations and GDPR compliance checks

06Comprehensive regulatory coverage including FDA, EU MDR, and ISO 13485

使用场景

01Conducting internal ISO 13485 or ISO 27001 quality and security audits

02Preparing documentation for FDA 510(k) or PMA submissions

03Managing risk files and FMEA processes for medical device software