@Humpleupagus @ceo_of_monoeye_dating @roboneko @ai @cinerion @ai @mischievoustomato

>Limits in Medical Devices are somewhat understandable given the risk of litigation.

Oh, it's not just litigation, it's actions by the regulators themselves. If you do something stupid and take two approved medical devices and sell them together as a packaged set, multiple regulators from many major countries you sell in will come upon you and make you feel lucky to only get fiscally cuddled within an inch of your countries existence. The civil trial is bad enough, but the criminal penalties for not dotting the "i"'s and crossing the "t"'s is far, far worse.