Dobby1979
Involved In Discussions
Hi All.
I have read a few posts about sample plans around design validation and all the examples seem to typically be in relation to manufacturing. Does anyone have any experience with proving substantial equivalence for a Software Medical Device.
There does not seem to be any specific guidance around this that I have found so far.
Thanks
I have read a few posts about sample plans around design validation and all the examples seem to typically be in relation to manufacturing. Does anyone have any experience with proving substantial equivalence for a Software Medical Device.
There does not seem to be any specific guidance around this that I have found so far.
Thanks