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FDA QSR Audit Prep

Pressure-tests US medical-device quality system readiness with six FDA-style audit questions

Source Download skill
Repository
alirezarezvani/claude-skills
Stars
29,149
Licence
MIT
Files
1 file

What it does

This skill makes the agent act like a strict FDA auditor reviewing a medical device company's quality system under 21 CFR 820 (the Quality System Regulation, now QMSR). It asks six hard questions covering complaints and adverse event reporting, process validation, device history records, corrective and preventive actions, labeling, and past FDA observations (Form 483s). It then produces a structured readiness report with a traffic-light verdict and top three actions.

Great for

  • Quality and regulatory teams preparing for an annual internal QSR audit or an FDA inspection
  • Compliance staff responding to a Form 483 or deciding on a recall
  • Consultants who want a structured mock-inspection checklist for US medical device makers

Skip it if

  • Final regulatory decisions or legal advice: the skill's own output says Warning Letter responses, recall decisions and 510(k)/PMA strategy disputes need outside counsel
  • Companies outside the US medical-device context, where the FDA rules do not apply
  • Relying on its figures as proof of compliance: it only structures a review and does not check your actual records

Try asking

  • “Run an FDA QSR audit prep for our infusion pump line before the annual internal audit”
  • “We just received a Form 483 with three observations, help me plan the response”
  • “Walk me through the six FDA questions for our latest product launch labeling and UDI”
Step-by-step guide: how to use FDA QSR Audit PrepInstall, first run, examples, tips and FAQs

Install in 3 steps

  1. 1

    Download the skill

    The ZIP contains the 1 original files, the MIT licence and an attribution note.

    fda-qsr-audit-prep.zip
  2. 2

    Add it to your agent

    Claude Code (all projects)

    mkdir -p ~/.claude/skills && unzip fda-qsr-audit-prep.zip -d ~/.claude/skills/

    Claude Code / Agent SDK (this project only)

    mkdir -p .claude/skills && unzip fda-qsr-audit-prep.zip -d .claude/skills/

    Claude apps (web/desktop): Settings → Capabilities → Skills → Upload skill, and choose the ZIP.

  3. 3

    Ask for the task

    No special command needed — the agent reads the skill's description and loads it when your request matches. Try one of the prompts above.

Get better results

  • Provide real records (complaint logs, DHR samples, CAPA list) rather than summaries, so the answers reflect actual evidence
  • Treat the verdict and percentages as a starting structure to verify, not a substitute for a qualified regulatory professional's review
  • Check the referenced scripts and paths exist and read them before running, since they execute on your machine and the scripts were not included in the reviewed file

What's inside

  • SKILL.md

Redistributed unmodified from alirezarezvani/claude-skills under the MIT licence. The assessment was drafted with AI from the skill's files on 2026-10-29. Skills can instruct your agent to run code — read SKILL.md and any scripts before installing.