ISO 13485 extended Site (Two companies)

#1
Hello,
We are a medical devices manufacturer (A) according to ISO 13485. The scope of our certification is: Design and development, manufacture and distribution of medical devices. If we want to separate Design and Development into a new company (B) with different name but under mother company (A), can we consider Company B as extended site for Company A?
Thanks
 
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#3
Hello,
We are a medical devices manufacturer (A) according to ISO 13485. The scope of our certification is: Design and development, manufacture and distribution of medical devices. If we want to separate Design and Development into a new company (B) with different name but under mother company (A), can we consider Company B as extended site for Company A?
Thanks
I would think you would be best to discuss with your registrar/Notified Body. Asking here is OK but any reply here is no guarantee that your registrar/Notified Body will agree.
 
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