Supplier Assessment for Hardware supporting SaMD

[Cork_EODEA]

Producing SaMD... what Supplier Assessments are needed for the hardware used in every day to test and develop the software?

Is Supplier assessment needed of the hardware provider, or the reseller, other?

Appreciate opinions.

 

[yodon]

Well, supplier assessments need to be commensurate with the risk so what are the risks associated with equipment from those suppliers?

My guess is that the risk is pretty low so the assessment can be minimal. Generally, for commercially-available products, I don't even do an assessment.