ISO 13485 QMS Builder
Guides building or improving a medical device quality system to ISO 13485 standards.
by borghei · ★ 976 on GitHub
What it does
You describe your current processes, documents, and gaps. Claude walks through quality manual setup, document control, internal audits, supplier checks, and the validation work needed for certification. You get a structured implementation plan and a readiness checklist.
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