Earlier quoted context omitted.
I worked on similar software that ran on Windows, though the decision was made 18 years ago. It was driven by: * GUI dev tools were an order of magnitude better than under linux * nidaq (very common daq and dio cards) didn't have or had flaky linux drivers. usb may be a better choice today but was not then available. Plus it's convenient/less expensive to push functionality to the computer side and minimize embedded…
every software update to the machine has to be FDA certified Interesting. Does that imply that every Windows update Microsoft releases has been FDA-certified already?
Trust in the company's ability to properly validate the device is tempered by regular FDA (and other regulatory bodies) audits of their development process and process data, test reports and a general desire to stay in business. FDA can and will take your product off the market if it appears to be unsafe and the company does not respond appropriately.