In the US, if it is a Class 3 device and "FDA-approved", currently you are out of luck (Federal preemption). On the other hand, if it is a Class 2 or Class 1 device, it is adminstratively cleared based upon materials submitted by the manufacturer (not "approved" by the FDA) and manufacturers get sued all the time for faulty design, faulty manufacturing, faulty claims, etc.
IMHO, the arguement that software is special or different is just specious. Software engineering, exercising greater care, doing more careful and comprehensive testing just cost too much time and money, especially when you have already trained your customer base to live with the flaws at a given price point.
GF we should deliver a better product, if we have to sell less or at a higher price. Where is the fun in that?
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