Is it suitable for Software as a Medical Device (SaMD)?

Absolutely. It is designed to align engineering design controls and software validation processes with healthcare regulatory requirements and risk-benefit analysis.

Which regulatory standards does this skill support?

It supports a wide range of global standards including ISO 13485 (QMS), EU MDR 2017/745, FDA (510k/PMA), ISO 27001 (ISMS), and GDPR/DSGVO data privacy regulations.

How does it handle CAPA management?

The skill guides users through problem definition, root cause analysis (5-Why, Ishikawa), corrective action planning, and effectiveness verification, ensuring all outputs are ISO 13485 compliant.

Can this skill help with audit preparation?

Yes, it provides automated gap analysis, generates evidence checklists, reviews document control status, and facilitates mock audits for both internal and external certification reviews.

Quality & Regulatory Compliance Manager

Name: Quality & Regulatory Compliance Manager
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

安全与测试

Facilitates compliance with ISO 13485, EU MDR, FDA, and GDPR standards for medical device and healthcare software development.

This skill serves as a comprehensive regulatory affairs and quality management orchestrator specifically designed for the medical device and healthcare industries. It automates complex compliance workflows, including audit preparation for ISO 13485 and ISO 27001, technical documentation for EU MDR, and FDA submission strategy. By coordinating specialized agents for risk management, CAPA investigation, and data privacy (GDPR), it ensures that engineering teams maintain high-quality standards and meet rigorous global regulatory requirements throughout the product lifecycle.

主要功能

010 GitHub stars

02EU MDR Technical Documentation generation per Annex II/III requirements

03GDPR and DSGVO privacy impact assessments and data processing mapping

04FDA 510(k), PMA, and De Novo pathway guidance and submission planning

05Automated ISO 13485 and ISO 27001 gap analysis and audit preparation

06End-to-end CAPA management including root cause analysis and verification

使用场景

01Managing complex CAPA investigations following product quality incidents or audit findings

02Preparing for a notified body audit for ISO 13485 or ISO 27001 certification

03Generating structured technical files and clinical evaluation plans for EU MDR compliance

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 cs-quality-regulatory

For use in Claude.ai and ChatGPT

主要功能

010 GitHub stars

02EU MDR Technical Documentation generation per Annex II/III requirements

03GDPR and DSGVO privacy impact assessments and data processing mapping

04FDA 510(k), PMA, and De Novo pathway guidance and submission planning

05Automated ISO 13485 and ISO 27001 gap analysis and audit preparation

06End-to-end CAPA management including root cause analysis and verification

使用场景

01Managing complex CAPA investigations following product quality incidents or audit findings

02Preparing for a notified body audit for ISO 13485 or ISO 27001 certification

03Generating structured technical files and clinical evaluation plans for EU MDR compliance

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 cs-quality-regulatory

For use in Claude.ai and ChatGPT