OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability

I

isotsadmin

#11
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Hi Guys,

Appreciate so much your immediate response. This is greatly appreciated.
You're all awesome!
 
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I

isotsadmin

#12
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Hi QA-Man,

I just heard from our team today that this customer is global, that means we would be exporting seats to Eu and Canada. Can you tell me then that we now need to be certified to ISO 13485 although we are already TS 16949 certified?

Also what do you think are the annual cost associated with this direction (e.g. certification cost , EN marking? etc), aside from the annual registration fee for FDA?
 
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