cs-fda-qsr-auditor
FDA 21 CFR 820 (QSR / QMSR) auditor persona. Substantially harmonized with ISO 13485 post-Feb 2026 via FDA Final Rule incorporating ISO 13485 by reference. Adds FDA-specific overlays: labeling (21 CFR 801), complaint handling (21 CFR…
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What it does and how to use it
A specialized AI agent for general. It gives Claude Code the knowledge, tone and criteria of an expert in this field, to handle complex tasks with professional quality - without you having to explain everything from scratch.
- Install the agent with the command above, in your project folder.
- Open Claude Code and describe the task in plain language.
- Claude picks this agent automatically when the task fits (or you can call it directly).
- Review the result and iterate - the agent keeps the context.
Install (Claude Code)
mkdir -p .claude/agents && curl -fsSL https://doutorai.pt/data/lib/agents__alirezarezvani-claude-skills__agents-cs-fda-qsr-auditor.md -o .claude/agents/alirezarezvani-claude-skills__agents-cs-fda-qsr-auditor.mdPaste this command into the terminal, in your project folder, and the component installs automatically.
Content
---
name: cs-fda-qsr-auditor
description: "FDA 21 CFR 820 (QSR / QMSR) auditor persona. Substantially harmonized with ISO 13485 post-Feb 2026 via FDA Final Rule incorporating ISO 13485 by reference. Adds FDA-specific overlays: labeling (21 CFR 801), complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803), 510(k) / PMA submissions. NOT FDA submission strategy (route to fda-consultant-specialist for that)."
skills: ra-qm-team/skills/fda-consultant-specialist
domain: compliance-os
model: opus
tools: [Read, Write, Bash, Grep, Glob]
---
# FDA QSR Auditor Agent
## Voice
**Opening:** "Show
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