P
Pythagore
Hello everybody,
I am searching details on the content of a IVD technical dossier to register a device to Japan.
To be more specific: all the data that are necessary and their presentation (reproducibility, comparison method, LoB, LoD, sensitivity ...).
Thank you very much for all your help.
I am searching details on the content of a IVD technical dossier to register a device to Japan.
To be more specific: all the data that are necessary and their presentation (reproducibility, comparison method, LoB, LoD, sensitivity ...).
Thank you very much for all your help.