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Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach

cam5603

Starting to get Involved
#1
Hi everyone,

We have a Class IIa Medical Device that it is a wipe to apply on the skin. We have a few risks of use error with this product because the user interface is very simple and easy to understand...

Based on the first risk analysis of the product, do you think that I can avoid usability testing and summative evaluation with a justification?

Thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Based on the first risk analysis of the product, do you think that I can avoid usability testing and summative evaluation with a justification?
As such, probably. But the design (including IFU) will nevertheless need some sort of validation.
 
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