Does this skill support ISO 13485 compliance?

Yes, it is specifically designed to meet the requirements of ISO 13485 Clause 5.5.2 regarding Quality Manager responsibilities and management review workflows.

How does it help with Quality KPIs?

The skill includes a pre-built framework for identifying, measuring, and reporting SMART KPIs such as CAPA closure rates, First Pass Yield, and customer complaint trends.

Can it help me prepare for an FDA inspection?

It provides the structured oversight, accountability matrices, and evidence-gathering workflows necessary to demonstrate QMS effectiveness to regulatory bodies like the FDA.

Is this applicable for Software as a Medical Device (SaMD)?

Absolutely. While the frameworks are based on general MedTech standards, they are fully applicable to the quality governance required for medical software development.

Senior HealthTech Quality Manager (QMR)

Name: Senior HealthTech Quality Manager (QMR)
Author: borghei

byborghei

•

Productivity & Workflow

Streamlines HealthTech and MedTech quality management systems through automated management reviews, KPI tracking, and ISO 13485 compliance oversight.

This skill empowers Claude to act as a Senior Quality Manager Responsible Person (QMR), specifically tailored for the stringent requirements of HealthTech and MedTech industries. It provides comprehensive frameworks for conducting ISO 13485 management reviews, establishing measurable quality objectives, and monitoring critical KPIs like CAPA effectiveness and complaint rates. Whether you are preparing for FDA inspections or auditing internal quality culture, this skill ensures regulatory compliance, data-driven governance, and continuous improvement across your entire Quality Management System (QMS).

Key Features

01Real-time Quality KPI tracking with defined escalation thresholds

02Comprehensive CAPA oversight and internal/external audit management

03SMART quality objective setting and strategic alignment frameworks

04Automated ISO 13485 management review workflows and documentation templates

0550 GitHub stars

06Systematic quality culture assessments and improvement action plans

Use Cases

01Preparing documentation and evidence for Notified Body or FDA surveillance audits

02Establishing a data-driven quality dashboard for medical device manufacturing or SaMD

03Facilitating quarterly management reviews with executive stakeholders and department heads

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills quality-manager-qmr

For use in Claude.ai and ChatGPT

Download Skill