Please note: the contextual jurisdiction of this question is primarily the United States, but could be extended to European and Asian countries as well.
The OpenBCI is a recently-funded startup that will provide open source hardware (that is, open for any derivation but requiring attribution) capable of reading biodata such as "brain waves" (EEG), as well as heart (EKG) and muscle movement (EMG) data. It is clear from their site that this is not meant to be used as a medical and/or clinic/diagnostic tool, and is just a (high quality) hobbyist toy.
However, because it is a high quality "hobbyist tool", there's no reason why someone couldn't come along and build a commercial hardware device on top of its design (it's open source, afterall). This is actually pretty common in the electronics industry. You take an open source design (to save yourself the hardship of designing your own circuit/system from scratch) and then extend its capabilities to suit your commercial/proprietary interests.
I am interested in doing this, however the commercial device that I plan on building would be used in a biomedical/clinical setting. As such, there will be legal medical standards I need to ensure the hardware/firmware/software live up to. I believe this would be:
However I am not sure if this is a comprehensive list or not.
What I'm asking here is: how do I know what standards I must design my device (hardware + software) to live up to, for its intended purpose, inside the intended jurisdictions (which like I said are primarily USA, but might also be Europe and Asia)? Are there agencies I can call? Websites I can turn to? Places like Underwriters Laboratory ("UL") that I can consult?
To make a safe, legally-compliant and industry-compliant biomedical device, one must build that device to a certain set of standards. How do I find out what those standards even are?