The company being told to cease operations goes to show that not following these requirements are more than proof of the consequences, are they not? You’re right in that a company can decide to not follow requirements in attempt to save and money, but eventually they are allows going to get caught. The worst case scenarios for a company not following specific requirements would result in, as jr377 was speaking about, lawsuits and payouts. In the end the question is always, is it worth it? Personally, taking an illegal shortcut in attempt to save some money is not worth the consequences; especially when it comes to medical devices.