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

[cabjerk]

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]

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]

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.

 

[Marcelo]

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).

 

[cabjerk]

@Marcelo Antunes - thank you for this.

 

[Lokus200]

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.