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Quality and regulatory agent v1.0.0

Use this resource to prepare audits and regulatory documentation for medical devices

New

  • 347 downloads
  • 222 likes
  • 109 saves

Free

Install with the CLI

In a terminal, from the folder you want:

npx --yes palatekit@latest install quality-regulatory-advisor

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 covers medical device and healthcare compliance: ISO 13485, EU MDR 2017/745, FDA 510(k) and PMA, GDPR and ISO 27001. It orchestrates twelve ra-qm-team skills across quality management, regulatory affairs and information security. Four workflows: audit preparation with gap analysis and mock audit, MDR technical documentation with classification and GSPR checklist, CAPA investigation and GDPR compliance assessment.

Mostly picked by

Updated November 2, 2026

Card for the “Regulatory quality lead persona” skill

Details

Works in
Install guides
Generates with
Your agent's model
Uses
  • The ra-qm-team skills it orchestrates
Licence
MIT

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What you get

  • Audit checklists with evidence requirements and gap analysis
  • An MDR technical file structure and GSPR checklist
  • CAPA investigation support
  • A GDPR compliance assessment

Good fit for

  • Preparing an ISO 13485 or ISO 27001 audit
  • Classifying a device under EU MDR
  • Managing corrective actions and risk under ISO 14971

Not for

    Tags

    • regulatory
    • iso-13485
    • compliance

    About

    You say

    Prepare us for an ISO 13485 audit and run a gap analysis.

    Card for the “Regulatory quality lead persona” skill

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

    Show more

    Prerequisites

    You bring
    Your QMS documents, device description and audit scope
    Dependencies
    The ra-qm-team skills it orchestrates

    How to use it

    1. State the standard, device and audit scope
    2. Pick a workflow: audit prep, MDR file, CAPA or GDPR
    3. Review the checklists and documents with your quality lead

    Content preview

    Files

    • LICENSE1.1 KB
    • NOTICE-PALATEKIT.md0.5 KB
    • SKILL.md3.9 KB

    Origin and licence

    Listed unmodified

    Author
    alirezarezvani
    Source
    github.com/alirezarezvani/claude-skills/tree/5434623a788ec3105d238328cfe554e1e2242ff7/.gemini/skills/cs-quality-regulatory
    Licence
    MIT

    Notice

    « cs-quality-regulatory » (alirezarezvani, MIT) livré dans sa version d'origine : fiche en français et en anglais par PalateKit.

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