We have the same issue. I'm also desperate. What did you do to pass certification? The last thing they told us is: "Provide documentation of a report or peer-reviewed study that demonstrates the app's use of medical hardware works as described." Do we have to hire a 3rd party consultant to make a report about the app's use of the devices we connect to? Is that what they want? "Peer-reviewed" refers to an IT professional or a medical professional? This is not clear at all.