Risk assessment really is everywhere...so if you did not address it you probably should.
That said, it does not have to be science fiction...
In Reply to Parent Post by Jim-S
The materials themselves do not present any kind of risk to really be assessed.
I guess you wouldn´t state this without a reason. Put the "why" on paper and you have your risk assessment.
(Consider the device and its intended use, intended/unintended patient contact etc...i.e.)