N
northernscientist
Hi
We make Class II surgically invasive devices and I'm trying to find some official guidance on what would be an acceptable sample number for a new stability trial. The tests are generally going to be pass/fail. I know that AQL sampling isn't really appropriate for this kind of thing but I don't know where to look to figure out how to determine the sample size numbers scientifically. I should mention my statistics knowledge is a little rusty, so I might need something that's a pretty basic guide.
In the past I've been challenged by FDA on choice of sample numbers and it was very difficult to answer!
Can anyone help?
We make Class II surgically invasive devices and I'm trying to find some official guidance on what would be an acceptable sample number for a new stability trial. The tests are generally going to be pass/fail. I know that AQL sampling isn't really appropriate for this kind of thing but I don't know where to look to figure out how to determine the sample size numbers scientifically. I should mention my statistics knowledge is a little rusty, so I might need something that's a pretty basic guide.
In the past I've been challenged by FDA on choice of sample numbers and it was very difficult to answer!
Can anyone help?