How does it help with Management Reviews?

The skill includes scripts and templates for automating management review preparation, tracking KPIs, and ensuring all regulatory required topics are covered for C-level reporting.

Can it assist with internal and external audits?

Yes, it provides a strategic audit program oversight framework, including audit planning, resource allocation, and tracking effectiveness of corrective actions.

What regulatory standards does this skill support?

It is specifically designed for high-compliance environments, supporting ISO 13485, EU MDR 2017/745, and FDA QSR 21 CFR 820 requirements for medical devices.

Does this skill include automated monitoring tools?

Yes, it includes scripts for QMR dashboards, regulatory compliance trackers, and quality cost analyzers to provide data-driven insights into system effectiveness.

Quality Manager Responsible Person (QMR)

Name: Quality Manager Responsible Person (QMR)
Author: alirezarezvani

byalirezarezvani

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1,039

安全与测试

Provides comprehensive oversight for Quality Management Systems (QMS) and regulatory compliance in HealthTech and MedTech sectors.

关于

This Claude Code skill functions as a virtual Senior Quality Manager (QMR), providing a specialized framework for HealthTech and MedTech companies to manage their Quality Management Systems. It integrates deep expertise in ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820 to help teams navigate complex regulatory landscapes. The skill offers automated tools for compliance tracking, management reviews, and performance monitoring, ensuring that quality standards are not just met, but strategically integrated into the organization's core business processes and culture.

主要功能

Comprehensive QMS oversight based on ISO 13485 accountability frameworks
Multi-jurisdictional compliance tracking for EU MDR, FDA QSR, and international standards
1,039 GitHub stars
Interface management for Notified Bodies, Competent Authorities, and FDA communications
Automated management review preparation with real-time quality performance dashboards
Strategic quality planning tools to align regulatory compliance with business objectives

使用场景

Preparing for FDA inspections, ISO certification audits, or Notified Body assessments
Generating automated quarterly quality performance reports for executive leadership teams
Conducting regulatory risk assessments and gap analyses for new medical device market entries

关于

主要功能

Comprehensive QMS oversight based on ISO 13485 accountability frameworks
Multi-jurisdictional compliance tracking for EU MDR, FDA QSR, and international standards
1,039 GitHub stars
Interface management for Notified Bodies, Competent Authorities, and FDA communications
Automated management review preparation with real-time quality performance dashboards
Strategic quality planning tools to align regulatory compliance with business objectives

使用场景

Preparing for FDA inspections, ISO certification audits, or Notified Body assessments
Generating automated quarterly quality performance reports for executive leadership teams
Conducting regulatory risk assessments and gap analyses for new medical device market entries