In the context of the later two, what benefits do you think it would add to development that their QMS process plus FDA PMA/510k submissions don't? Legit quest

In the context of the later two, what benefits do you think it would add to development that their QMS process plus FDA PMA/510k submissions don't? Legit question, not snark. For a doctor in a hospital (or building a bridge, or many of the other classic examples), there is often one opportunity to act and it better be right. The cost to being wrong is very high, so the gate is to qualify people before the action can be taken. But you can test the shit out of a car or medical device before it hits the market.