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FDA 21 CFR 820 (QSR/QMSR) audit prep v1.0.0

Use this resource to prepare an internal audit or FDA inspection of a medical device

New

  • 304 downloads
  • 211 likes
  • 210 saves

Free

Install with the CLI

In a terminal, from the folder you want:

npx --yes palatekit@latest install fda-qsr-audit-prep

With no option, the skill goes to ~/.agents/skills/; add --agent claude-code (or codex, cursor…) to target an agent.

First time: connect the CLI with

npx --yes palatekit@latest login

The command puts the scope through six auditor questions: complaints and MDR reports, process revalidation, device history records, CAPAs, labelling and Form 483 follow-up. It then sets the compliance status and tracks 510(k), PMA or IDE submissions.

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Updated November 2, 2026

Card for the “FDA 21 CFR 820 (QSR/QMSR) audit prep” skill

Details

Works in
Install guides
Generates with
Your agent's model
Licence
MIT

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What you get

  • SKILL.md: six evidence questions, from complaints to Form 483 follow-up
  • SKILL.md: two-step flow, compliance status then submission tracking

Good fit for

  • You are preparing the yearly internal audit of a medical device maker
  • You must respond to a Form 483 observation

Not for

    Tags

    • FDA
    • QSR
    • medical device
    • audit

    About

    You say

    “/compliance-os:fda-qsr-audit-prep on the sterilisation line for last quarter.”

    Card for the “FDA 21 CFR 820 (QSR/QMSR) audit prep” skill

    Skill published by alirezarezvani under the MIT license, delivered in its original version.

    Show more

    How to use it

    1. Install the skill in your agent's skills folder
    2. Ask your agent to prepare an internal audit or FDA inspection of a medical device
    3. Review and adjust the result

    Content preview

    Files

    • LICENSE1.1 KB
    • NOTICE-PALATEKIT.md0.5 KB
    • SKILL.md6.6 KB

    Origin and licence

    Listed unmodified

    Author
    alirezarezvani
    Source
    github.com/alirezarezvani/claude-skills/tree/5434623a788ec3105d238328cfe554e1e2242ff7/compliance-os/skills/fda-qsr-audit-prep
    Licence
    MIT

    Notice

    « fda-qsr-audit-prep » (alirezarezvani, MIT) livré dans sa version d'origine : fiche en français et en anglais par PalateKit.

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