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
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