Medical Device QMS Auditor
Plans and runs internal ISO 13485 audits for medical device quality systems.
by borghei · ★ 976 on GitHub
What it does
You tell Claude which processes and clauses are in scope and any past findings. Claude builds a risk-based audit schedule, checklist, and nonconformity tracker aligned to ISO 13485. You get an audit plan ready for internal or certification audits.
Who it’s for
A good fit for healthcare professionals and health businesses, people who review contracts and legal documents and people who run the day-to-day of a business.
Do you need to code?
No. You can use this without writing or editing any code.
How to install
Add it as a skill, or as part of its plugin. This skill also ships inside a plugin, so you can upload just this skill to Claude, or install the whole plugin it comes in. See the step-by-step guide.
Safety note
Runs a bundled Python script on your computer; gives compliance guidance, not legal advice.
Script files included: 1
As with any add-on, only install skills from sources you trust, and read what it does first.
License
MIT