They're really not very complicated; the requirements can be written out in a few pages. I'd say they're a bit more complicated than your fridge, but a lot less

They're really not very complicated; the requirements can be written out in a few pages. I'd say they're a bit more complicated than your fridge, but a lot less complicated than a car. Generally the primary barrier to entry for manufacturing medical devices is not their complexity but the onerous requirements of certification by the FDA. On the whole that's a good thing, since it means that properly certified medical devices are rarely built by fly-by-night organizations that disappear once they have your money.