Re:Hacked Raspberry Pi turned into artificial pancreas
by OopsCriticality on Friday August 28, 2015 @01:13PM
(#10136663)
I sure hope not.
This is an interesting personal project, but it is far from how medical devices should be (and are) developed. Where is the risk analysis, for example? Or the FMEA? Was the software developed under ISO 62304? Etc.
There's a lot of activity that happens in a regulated industry that is completely missing here, which is why I see this as a poor example.
This is an interesting personal project, but it is far from how medical devices should be (and are) developed. Where is the risk analysis, for example? Or the FMEA? Was the software developed under ISO 62304? Etc.
There's a lot of activity that happens in a regulated industry that is completely missing here, which is why I see this as a poor example.