Good questions!
First go-round is a proof-of-concept, outside of "real" device development, so no need for standard DHF material. This is described somewhat in our Project Overview document that's linked at the bottom of the readme, but maybe isn't so obvious. Better to keep heavyweight medical device process out of the way until we are clearer about what needs to be done - then we'll go through standard requirements through verification, traceable, conforming to IEC 62304 and ISO 13485, etc.
That said, EEG essential performance is spelled out by IEC 80601-2-26, so we'll be doing initial verification of the POP against that standard. Essential performance is what's... well essential, so that's nice to demonstrate.
FDA classifies these devices, both for depth of anesthesia and standard clinical EEG, as Class II. I believe that they're both IIA in the EU.
Software safety class is probably B, might be C (not so much difference between these in 62304). It also depends on the risk controls we decide to implement on the systems, e.g., one trick is to have redundant (but different) processors running different software and if there's a substantial difference then shut down. That could even drive it to Class A, which would be lovely.