qsr_compliance_requirements

Name: qsr_compliance_requirements
Author: alirezarezvani

Quality System Regulation (QSR) Compliance

Content Preview

# Quality System Regulation (QSR) Compliance

Complete guide to 21 CFR Part 820 requirements for medical device manufacturers.

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## Table of Contents

- [QSR Overview](#qsr-overview)
- [Management Responsibility (820.20)](#management-responsibility-82020)
- [Design Controls (820.30)](#design-controls-82030)
- [Document Controls (820.40)](#document-controls-82040)
- [Purchasing Controls (820.50)](#purchasing-controls-82050)
- [Production and Process Controls (820.70-75)](#production-and-proce

How to Use

Recommended: Install to project (local)

mkdir -p .claude/skills
curl -o .claude/skills/qsr_compliance_requirements.md \
  https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/fda-consultant-specialist/references/qsr_compliance_requirements.md

Skill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.

Alternative: Clone full repo

git clone https://github.com/alirezarezvani/claude-skills

Then reference at ra-qm-team/fda-consultant-specialist/references/qsr_compliance_requirements.md