| PSA. Do not listen to advice like this. >complex systems are a pretty good shield from accountability in practice today. Maybe complex legal systems are, but complex software systems offer you no such protection. My field for the past few decades has been diagnostic medical software. In that field, the 501K you got is kind of entering you into an ironclad agreement with the government. There's almost no way out of it. 501K certs significantly simplify, (for the government), holding you accountable. You have made attestations to suitability directly to the federal government. And the way our chief counsel explained it to us, literally each signature you sent to the government, for each feature that failed, is actually a single count of lying to the federal government. Please, please, please people, don't listen to comments like the one above. Everything should be run by your qualified legal expert. Getting things right up front is so much easier than trying to fix things when the inevitable happens. Alternatively, stick to fields free from regulation. That's also a viable strategy. But to just trust that the legal system is complicated and the technology you're deploying is complicated, so the feds will never get me? That's the start of a lot of really bad stories. |