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Built for the Claude Code community with Claude Code by @mertduzgun

Independent project, not affiliated with Anthropic
  1. Skills
  2. /
  3. alirezarezvani
  4. /
  5. claude-skills
  6. /
  7. Quality Manager Qms Iso13485

Quality Manager Qms Iso13485

Editor's Note

This handles ISO 13485 quality management system workflows for medical device companies. You'd reach for it when dealing with document control, CAPA processes, supplier management, or audit preparation in a regulated environment. It's built around the specific requirements of medical device QMS rather than generic quality management, which matters if you're actually trying to maintain compliance. The structure suggests it can walk through risk management documentation and design control procedures, though without seeing the implementation details it's hard to say how opinionated it is about your existing processes. Useful if you're tired of reinventing QMS prompts every time you need to draft a deviation report or update an SOP.

Install

npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-manager-qms-iso13485
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Installs721
GitHub Stars16.9k
Categories
Testing & QACode Review & Quality
First SeenJun 3, 2026
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