Does this skill support ISO 13485 standards?

Yes, it is specifically designed to manage quality systems according to ISO 13485 requirements, including Clause 5.5.2 for QMR accountability and Clause 5.6 for management reviews.

Can it help track the cost of quality?

Yes, it includes specialized scripts for quality cost analysis, categorizing expenses into prevention, appraisal, and failure costs to help optimize quality ROI.

How does it help with management reviews?

The skill provides automated scripts and templates to facilitate quarterly reviews, generate performance dashboards, and streamline quality communication with the board.

Can I use this for FDA and EU MDR compliance?

Absolutely. It includes monitoring frameworks for EU MDR 2017/745 status and verification processes for FDA QSR 21 CFR 820 compliance.

Quality Manager Responsible Person (QMR)

Name: Quality Manager Responsible Person (QMR)
Author: pur3v4d3r

bypur3v4d3r

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セキュリティとテスト

Provides comprehensive quality system governance and regulatory compliance oversight for HealthTech and MedTech organizations.

概要

This Claude Code skill equips the AI to serve as a Senior Quality Manager Responsible Person (QMR), specifically designed for the stringent requirements of the HealthTech and MedTech industries. It offers a structured framework for managing Quality Management Systems (QMS) in accordance with ISO 13485, EU MDR, and FDA 21 CFR 820 standards. By integrating quality governance, strategic planning, and regulatory interface management, this skill assists organizations in maintaining multi-jurisdictional compliance, fostering a robust quality culture, and automating complex reporting tasks such as management reviews and KPI tracking.

主な機能

1 GitHub stars
Quality culture development and leadership framework implementation
Automated management review preparation and quality performance reporting
Multi-jurisdictional compliance tracking for EU MDR, FDA QSR, and ISO 13485
Strategic quality planning and ROI analysis for quality investments
Audit program oversight and regulatory authority relationship management

ユースケース

Automating quarterly management reviews and KPI dashboards for C-level executives
Establishing a standardized Quality Management System (QMS) governance framework
Conducting regulatory gap analysis and impact evaluations for new market entries

概要

主な機能

1 GitHub stars
Quality culture development and leadership framework implementation
Automated management review preparation and quality performance reporting
Multi-jurisdictional compliance tracking for EU MDR, FDA QSR, and ISO 13485
Strategic quality planning and ROI analysis for quality investments
Audit program oversight and regulatory authority relationship management

ユースケース

Automating quarterly management reviews and KPI dashboards for C-level executives
Establishing a standardized Quality Management System (QMS) governance framework
Conducting regulatory gap analysis and impact evaluations for new market entries