Conformity assessment based on a quality management system or production quality assurance

Piroy

Registered
Hello,

For Class IIa medical device software I would have liked to know whether it is possible to have certification based on Annex XI Part A of the new Regulation, i.e. production quality assurance, rather than system quality assurance based on Annex IX which is much more complex.
In order to move away from the design and development quality corresponding to point (d) 2.2 of Annex IX of the new regulation, and also the point 7.3 of ISO 13485.

I cannot find a justification that mentions how we can do without design and development quality.

Yours sincerely
 

twanmul

Involved In Discussions
It will depend on whether your Notified Body has the production quality assurance conformity assessment procedure as part of their designation for your type of device. If they are not, then you're either stuck with quality assurance system assessment or need to change NB.
 

twanmul

Involved In Discussions
You don't need to ask them, you can find that here by clicking on your NB and then selecting Regulation 2017/745 on their page. You'll need to go down to your product type (your GNDM code may be helpful here) and see the approved procedures in the column next to it.
 
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