A
azpatt
Hi everyone!
Currently working for a med device start up in the US.
I know that there are FDA guidance docs on Terminally Sterile Medical Device Packaging, however, we are having some trouble with our device which is non-sterile. We don't know how to conduct Packaging Validation and how to define our sample size.
All help will be appreciated!!! Thanks!
Currently working for a med device start up in the US.
I know that there are FDA guidance docs on Terminally Sterile Medical Device Packaging, however, we are having some trouble with our device which is non-sterile. We don't know how to conduct Packaging Validation and how to define our sample size.
All help will be appreciated!!! Thanks!