I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they’ll take a mile. However, if something during the production of an medical device goes wrong, and the company becomes scrutinized, they are going to be cross examined to see if they truly did go as far as possible. Either the company really did try their best and something went wrong, or they tried to get away with something, and they’ll either convict themselves or have to purger themselves. I truly do think “asa far as possible” is a feasible restriction