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


Starting to get Involved
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,


Captain Nice
Staff member
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.


Starting to get Involved
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.
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).


Starting to get Involved
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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