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Medical device software compliance review v1.0.0

Use this resource to review medical device software compliance before a quality review

New

  • 423 downloads
  • 185 likes
  • 207 saves

Free

Install with the CLI

In a terminal, from the folder you want:

npx --yes palatekit@latest install medical-device-software-audit

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 agent examines a design file, validation protocol or CAPA analysis against IEC 62304, 21 CFR Part 820 and ISO 14971. It flags gaps and missing evidence. It does not replace a certified auditor or FDA approval.

Mostly picked by

Updated November 2, 2026

Card for the “Medical device software compliance review” skill

Details

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

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What you get

  • SKILL.md: review method for design history files and validation protocols
  • SKILL.md: CAPA root-cause review example and best practices

Good fit for

  • You are preparing a technical file for a software medical device
  • A software validation protocol must be checked before a quality review

Not for

    Tags

    • medical device
    • IEC 62304
    • compliance
    • validation

    About

    You say

    “Review this software validation protocol against IEC 62304 and list the missing evidence.”

    Card for the “Medical device software compliance review” skill

    Skill published by sickn33 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 review medical device software compliance before a quality review
    3. Review and adjust the result

    Content preview

    Files

    • LICENSE1.1 KB
    • NOTICE-PALATEKIT.md0.5 KB
    • SKILL.md4.2 KB

    Origin and licence

    Listed unmodified

    Author
    sickn33
    Source
    github.com/sickn33/agentic-awesome-skills/tree/e9809578fd426a284af017c5db99f8eb6628e6ca/skills/fda-medtech-compliance-auditor
    Licence
    MIT

    Notice

    « fda-medtech-compliance-auditor » (sickn33, MIT) livré dans sa version d'origine : fiche en français et en anglais par PalateKit.

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