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Under ISO 13485:2016 it requires concession approval from customers for product dispositioned as "use as is". We supply product that could end up in countless Doctors offices or hospitals. The disposition generally is for some kind of minor cosmetic defect or internal marking deviation.
The issue is that we could send a permission form to all of these customers and never receive a response back because 9 out of 10 do not care or understand what we are requesting. Is their a way to circumvent doing this since we hold design control and the nature of the nonconformity does not effect safety of efficacy of the product?
The issue is that we could send a permission form to all of these customers and never receive a response back because 9 out of 10 do not care or understand what we are requesting. Is their a way to circumvent doing this since we hold design control and the nature of the nonconformity does not effect safety of efficacy of the product?