Can it help automate management reviews?

Yes, it includes scripts and templates for quarterly management reviews, real-time KPI dashboards, and strategic quality planning for C-level executives.

How does it assist with audit preparation?

The skill provides an audit program management framework that handles strategic planning, external audit coordination, and corrective action effectiveness verification.

What regulations does this Claude Code skill cover?

The skill primarily focuses on ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820 (QSR) for medical device and health technology organizations.

Is this tool suitable for international market expansion?

Absolutely. It is designed for multi-jurisdictional oversight, helping manage relationships with various Notified Bodies, Competent Authorities, and the FDA.

QMR Senior Quality Manager

Name: QMR Senior Quality Manager
Author: pur3v4d3r

bypur3v4d3r

•

Security & Testing

Governs MedTech and HealthTech quality management systems through strategic regulatory oversight and ISO 13485 compliance leadership.

The Quality Manager Responsible Person (QMR) skill transforms Claude into a senior-level compliance expert tailored for HealthTech and MedTech environments. It provides structured guidance on implementing ISO 13485 standards, managing EU MDR and FDA 21 CFR 820 requirements, and leading strategic quality reviews. This skill is essential for organizations needing to automate quality performance monitoring, coordinate regulatory authority interfaces, and foster a robust quality culture while ensuring complete accountability across all jurisdictions and development stages.

Key Features

01Multi-jurisdictional compliance tracking for EU MDR, FDA QSR, and ISO 13485

02Cross-functional quality integration across R&D, manufacturing, and supply chains

031 GitHub stars

04Automated quality KPI dashboards and comprehensive cost-of-quality analysis

05Strategic management review frameworks with executive reporting automation

06Internal and external audit program oversight with gap analysis and remediation

Use Cases

01Preparing for FDA inspections or Notified Body certification audits

02Establishing a compliant Quality Management System (QMS) for a medical device startup

03Monitoring real-time quality metrics and regulatory risk escalations for senior leadership

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add pur3v4d3r/pur3-pkb-codebase quality-manager-qmr

For use in Claude.ai and ChatGPT

Download Skill