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Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed?

cabjerk

Starting to get Involved
#1
In Medical device mfg (class 2 13485:2016) is a deviation acceptable? If not or is, where is it stated in the regulations?

Thank you,
 

Marc

Captain Nice
Staff member
Admin
#2
I'm not in medical devices, but I can tell you the first question is - A deviation from what? A print? A processing deviation? An ISO 13485 requirement?

You will have to be more specific.
 

cabjerk

Starting to get Involved
#3
From Mfg instructions mainly.
But more of a general question.
We (Quality Group) have had a discussion that in Medical Device NO deviation is acceptable. But I can't find any yes/no in any of the regulations.
 
#4
Formally, the acceptance of deviation is more related to the finished product. For example, ISO 13485 allows that a non-conforming final product be liberated under concession if the non-conformity does not affect compliance with regulatory requirements (mainly related to product safety and performance).
 

Lokus200

Starting to get Involved
#6
You can release it under concession, however, you cannot do it forever. If for whatever reason that is one-off occurrence you can use a concession, otherwise you need to initiate a change control and update your process.
 
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