zlacker

The UI is one of the most important parts of a machine, look at the Therac-25! The FDA regulations require a lot of effort goes into the human factors, too, and the UI definitely had to be as reliable as the rest of the device and be as well engineered as the rest.

https://www.fda.gov/medical-devices/human-factors-and-medica...

Honestly, the FDA regulations go too far vs the EU regs. The company I worked for was based in the EU and the products there were so advanced compared to our versions. Ours were all based on an original design from Europe that was approved and then basically didn’t charge for 30 years. The European device was fucking cool and had so many features, it was also capable of being carried around rather than rolled. The manufacturing was almost all automated, too, but in the USA it was not at all automated, it was humans assembling parts then recording it in a computer terminal.