J
We do, on the other hand, determine as an element of design control whether a product must be able to be sterilized.
However for a single use device that the customer may want to buy in bulk, non sterile (maybe in order to include in a theatre pack /ER pack of their own design before sterilization, as Roland suggests), ensuring that the device can be sterilized and stipulating the method, provides additional value to the customer, without adding cost that offers them no value, and may even increase their costs (if they have to repackage).
Thanks for the concept,
Jimmy