Medical Device Regulatory Strategist
Builds a regulatory submission strategy for medical devices across FDA, EU, and other markets.
by borghei · ★ 976 on GitHub
What it does
You give Claude the device's classification, intended use, and target markets. Claude maps out which regulatory pathway and submissions apply in each market and sequences the work. You get a regulatory strategy and a tracker for submissions.
Who it’s for
A good fit for healthcare professionals and health businesses and people who review contracts and legal documents.
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 regulatory 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