Re: Safety Assurance Case Reports
Well, that?s a little more difficult.
In my opinion, it would have to be with the risk manager, but most manufacturers still do not have that role.
Anyway, it still should be the leader of the risk management team, so whatever function you put as the head of that team, it should be it. In my opinion, it would need to be someone from R&D (lot?s of manufacturer put this into quality but really risk management has nothing to do with quality).