FDA Device Inspection Prep
Gets a medical device company ready for an FDA quality system inspection.
by borghei · ★ 976 on GitHub
What it does
Share your quality records and the inspection timeline with Claude. Claude checks your documentation against FDA quality system requirements, flags missing pieces, and builds a prep schedule for the inspection or a 483 response. You get a readiness score and a clear action plan.
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 bundled Python scripts on your computer; Gives legal/financial/medical info - not professional advice.
Script files included: 2
As with any add-on, only install skills from sources you trust, and read what it does first.
License
MIT