I agree with your premise, but in this case, for a medical device it would also be a Quality Systems failure. Any change in a component is scrutinized and analyzed for impact. You have no idea how many times (as a software dev for medical devices), I've had someone from Manufacturing or Purchasing come to ask me "if we change (trivial part X) to a new vendor, what can go wrong and how can we test it?" as a precursor to executing a Change Plan.

I'm not kidding. Even something as seemingly trivial as changing the type of paint used on an enclosure can trigger weeks or months of analysis depending on what's in that enclosure.