ISO 13485 & EU MDR / Non-applicable clauses for supplier of component for medical device
As a supplier of component for medical device, which clauses will be not applicable for us?
Please select user.
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I do not have enough information here, but the following requirements can be marked as non-applicable :
Maybe there are some more requirements that can be marked as non-applicable, but for defining that I need more information regarding the product.
For more information regarding the ISO 13485:2016, please see following articles:
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