zlacker

That’s an odd thing to claim. I have worked on certified medical devices that run custom Linux distribution.

Mind you, that experience also severely soured me on the quality of medical software systems, due to poor quality of the software that ran in that distribution. Linux itself was a golden god in comparison to the crap that was layered on top of it.

>>voakba+(OP)
I'd like to hear more about that, but I assume it's much like the other poster here that described a Linux system that is a peripheral device attached to the actual medical device that does the medical shit.

>>ok_dad+V3
It is not a peripheral device if it runs the UI with all the main controls, is it?

>>gmueck+4h
No, do you have a concrete example of this strawman, though?

Edit: I should also add (probably earlier too) that all my examples are specific to the USA FDA process. I'm sure some other place might not have the same rules.

>>ok_dad+Qd1
I can't see how you can make out a strawman in what I said. There are medical devices where the UI is running on a processor separate from the controller in charge of the core device functions. The two are talking to each other and there is no secondary way of interacting with the controller. This lessens the requirements that are put on the part running the UI, but does not eliminate them.

I'm mostly familiar with EU rules, but as far as I know the FDA regulations follow the same idea of tiered requirements based on potential harm done.

>>gmueck+uq1
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.

>>ok_dad+V3
These were not peripherals. We are talking devices that would be front line in an emergency room. Terrifying.