Medical Device Risk Manager
Runs ISO 14971 risk analysis for medical devices, from hazards through residual-risk evaluation.
by borghei · ★ 976 on GitHub
What it does
You describe the device, its hazards, and how it's used. Claude scores each risk, applies the acceptability matrix, and suggests control measures following ISO 14971. You get a risk register and residual-risk assessment ready for your file.
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