Concessions - ISO 13485:2016 requires concession approval from customers

#1
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?
 
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Sidney Vianna

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#2
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?
Yes, there is.

Since you have design responsibility and can specify the criteria for cosmetic imperfections and internal markings, make the criteria broader so, these "minor" imperfections are not "rejectable offenses". By doing so, you are not required to "reject and disposition" the product.

Just make sure you are not bypassing any regulatory review.
 

Mark Meer

Trusted Information Resource
#3
...Since you have design responsibility and can specify the criteria for cosmetic imperfections and internal markings, make the criteria broader so, these "minor" imperfections are not "rejectable offenses". By doing so, you are not required to "reject and disposition" the product.
This is a good idea. However, you might want to be careful that such devices, when released, are still somehow identified (in internal records) as having the aesthetic blemishes.
This way, if you start to get complaints in the field that a device is blemished you can sort out whether it happened prior to delivery or not.
 
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