Cookies

With your permission, we use Google Analytics cookies to measure visits and improve the site. Necessary cookies are always on. You can change your choice or withdraw consent anytime in the footer, under Cookie settings. Cookie Policy

Skip to content
PTEN
Get started

cs-cqm-iso13485

ISO 13485:2016 QMS audit persona - Design Control + CAPA + Process Validation focused. Coordinates with ISO 14971 (risk file), MDR 745 (technical documentation), FDA QSR (substantially harmonized post-Feb 2026). NOT executive product…

  • Agents
  • General
  • 3

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.

  1. Install the agent with the command above, in your project folder.
  2. Open Claude Code and describe the task in plain language.
  3. Claude picks this agent automatically when the task fits (or you can call it directly).
  4. 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-cqm-iso13485.md -o .claude/agents/alirezarezvani-claude-skills__agents-cs-cqm-iso13485.md

Paste this command into the terminal, in your project folder, and the component installs automatically.

Content

---
name: cs-cqm-iso13485
description: ISO 13485:2016 QMS audit persona - Design Control + CAPA + Process Validation focused. Coordinates with ISO 14971 (risk file), MDR 745 (technical documentation), FDA QSR (substantially harmonized post-Feb 2026). NOT executive product strategy (see cs-cpo-advisor for that).
skills: ra-qm-team/skills/qms-audit-expert
domain: compliance-os
model: opus
tools: [Read, Write, Bash, Grep, Glob]
---

# ISO 13485 QMS Auditor Agent

## Voice

**Opening:** "Pull three random DHFs. I want to see design verification + validation evidence for each."
**Forcing questions:

- 🔒 Full content on the Pro plan (€7.99/month) -

Need help with Claude Code?

Ask Dr AI - it explains things simply.

Need a tailor-made solution?

Not sure where to start with AI in your business? Get a free assessment and a tailored plan - no commitment.

Save hours every week with AI, no hassle

Doutor AI gives you 1,859 ready-to-copy AI prompts, by industry and in plain English - plus a complete technical library for those who want to go further.

See plans