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Criteria and when to carry out Setup Approval

QMS for Medical Device Companies
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Ron Rompen

Ron Rompen

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#2
#2
Without knowing your processes and customer requirements, it is difficult to provide a meaningful answer to your question.

In general, unless otherwise specified by your customer, the criteria for performing setup inspection is something that YOU need to determine, based on your manufacturing processes and the risk(s) of failure that you identify.
 
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