K
I know the question is very subjective but please share your opinion .
I was asked to write regulations for a medical application which is an accessory to already existed medical device . I gave him write up from a link of FDA regulations But they are not convinced . I gave him write up from the link of GMP AKA Quality standards and gave them required documents list also but still they are demanding more . Like human interface guidelines of apple .
What should I write other than this ? Any suggestions ?
P.S>I gave him the mobile regulations guidelines released by FDA some times back , again they dont seem convinced.
I was asked to write regulations for a medical application which is an accessory to already existed medical device . I gave him write up from a link of FDA regulations But they are not convinced . I gave him write up from the link of GMP AKA Quality standards and gave them required documents list also but still they are demanding more . Like human interface guidelines of apple .
What should I write other than this ? Any suggestions ?
P.S>I gave him the mobile regulations guidelines released by FDA some times back , again they dont seem convinced.

Last edited by a moderator:
]