The FDA does not forbid the use of general purpose OS. However, they are strictly regulated. For every SOUP, software of unknown provenance/pedigree, that is ev

The FDA does not forbid the use of general purpose OS. However, they are strictly regulated. For every SOUP, software of unknown provenance/pedigree, that is every piece of software that was not developed specifically for a medical device, this is the responsibility of the manufacturer to provide performance requirements, test, risk analysis... Moreover, the manufacturer have the obligation to assess every known bug of every SOUP and provide fixes if this can endanger the patient. The issue is that to prove that a device is safe you have to execute costly tests. For a device I have been working on, we do endurance tests on multiple systems to simulate 10 years of use. Even with intensive scenario, on multiple systems it can take a few months. And if we encounter a single crash we reset the counter and start again. So in the end the product is safe but it is costly. This is why most of the time it is actually better to have the most simple stack possible on bare metal. But sometimes mistakes have been made, and you inherit a system full of SOUP and this is a nightmare to maintain. I actually except some shitstorm on Monday morning, luckily I am working more on the embedded side so no Windows for me but some other divisions will be affected.