Quality Manager Qmr

This one handles the top-level quality management role for HealthTech and MedTech companies, covering ISO 13485 Clause 5.5.2 responsibilities like QMS oversight, regulatory compliance across EU MDR and FDA QSR, and management reviews. It's built for quarterly C-level reporting, managing relationships with Notified Bodies and FDA, and running audit programs. Use it when you need strategic quality decisions rather than day-to-day quality operations. The framework is solid for multi-jurisdictional compliance tracking, though you'll still need domain experts for specific regulatory submissions. Good fit if you're setting up quality governance or preparing for regulatory inspections.

Install to Claude Code

npx -y skills add davila7/claude-code-templates --skill quality-manager-qmr --agent claude-code