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Hi Experts,
I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.
Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?
Also I would really appreciate if you could point me to a reference document to find this type of information.
Thank you!!
I look forward to your earliest response
I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.
Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?
Also I would really appreciate if you could point me to a reference document to find this type of information.
Thank you!!
I look forward to your earliest response
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