Device regulation document for medical application

K

kingkobra

#1
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. :deadhorse:
 
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sreenu927

Quite Involved in Discussions
#2
Hi Kingkobra,

Welcome to Cover!
Please detail you question as much as you can so that people can understand and answer you.
For which medical application and what is the type of accessory?
Did you find the product code of that instrument or accessory?
What FDA link did you provide?
What list of docs you have provided from GMP aka quality standards?

Who do you need to convince - your management or your client?

Regards,
Sreenu
 
K

kingkobra

#3
Thanks Shreenu :)

I will have to explain my management they will explain clients.

I have given documents made from FDA's standard links [I am not allowed here to post links until 5 posts :frust:]

Can you tell me about some must have things that should be included in the document ?

Thanks.
 
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