Exactly. This is how the medical device industry does it. One important part you skipped was the mandatory audits of the development process (often with little

Exactly. This is how the medical device industry does it. One important part you skipped was the mandatory audits of the development process (often with little or no warning: FDA audit team announces that they'll be there tomorrow). I honestly don't think there's any other realistic way of doing it properly. The true experts are the ones doing the work.