Does it include risk management features?

Absolutely. It integrates ISO 14971 risk management workflows directly into the design control and QMS processes.

Is it suitable for post-market surveillance?

Yes, it provides frameworks for managing customer feedback, complaints, and CAPA (Corrective and Preventive Actions) to monitor product performance post-launch.

Can it help with FDA 21 CFR 820 compliance?

Yes, the skill is designed to align with both ISO 13485 and FDA Quality System Regulations (QSR) for medical device manufacturers.

How does this skill assist with ISO 13485 certification?

It provides a structured implementation roadmap, gap analysis tools, and standardized documentation templates to align your organization with ISO 13485:2016 requirements.

What automation tools are included?

It includes specialized Python scripts for tracking QMS performance metrics, conducting document control audits, and automating management review preparation.

ISO 13485 QMS Manager

Name: ISO 13485 QMS Manager
Author: pur3v4d3r

bypur3v4d3r

•

생산성 및 워크플로

Manages and automates ISO 13485 Quality Management Systems for medical device organizations to ensure regulatory compliance and operational excellence.

This skill acts as a senior quality management specialist, providing comprehensive support for ISO 13485:2016 implementation and maintenance. It offers end-to-end guidance for medical device companies, covering everything from initial gap analysis and QMS design to document control, internal auditing, and management reviews. By leveraging integrated Python scripts for performance tracking and standardized templates for SOPs and design controls, it streamlines the complex regulatory path, ensuring your quality system is audit-ready and fully aligned with global medical device standards like MDR and FDA 21 CFR 820.

주요 기능

01End-to-end ISO 13485 QMS implementation roadmap and gap analysis

02Structured internal audit program with automated checklist generation

03QMS performance monitoring via automated metrics and dashboards

041 GitHub stars

05Risk management integration following ISO 14971 standards

06Automated document control lifecycle management and compliance auditing

사용 사례

01Preparing for certification or surveillance audits using automated compliance scripts

02Managing complex design controls and risk management files for new product development

03Establishing a new ISO 13485:2016 compliant system for a medical device startup

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add pur3v4d3r/pur3-pkb-codebase quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT

Download Skill