Comment by throwup238

> How would you go about regulating an open source medical device? The user can just plop whatever software on there that they want, and ultrasound themselves wherever… play with resonance and focusing, right?

The manufacturer will still need to validate their own firmware and subsequent updates. Whether it’s open source or not doesn’t matter because a huge part of the approval process is quality control tied to a specific manufacturer.

Anyone who plops their own software will be liable for the consequences and I doubt malpractice insurance would allow it in the vast majority of cases.