Spent some years working on an a class 2b diagnostic device. Potential for harm not that high, but the lack of rigour in testing leaves me wondering to this day whether it worked at all as advertised.
If medical devices are ever open sourced, millions of critical bugs are going to fall out.
Already happening with Diabetics. I know a girl that has cracked her pump for closed loop performance and she says the results are mostly better, but take close monitoring and an active hand.
It's a tricky thing still. Yes, the devices are buggy (all things are), but half of medical devices are used by people with below average intelligence (by definition). It's still a balancing act and is likely to be for a long time.
I tried to contact them regarding the fact that their url for jquery tools no longer resolves and that their SSL certificate has expired. I filled out the contact form and hit submit and then was presented with an empty results screen (probably because the js is broken). Hopefully they fix it up, but might not.
[0] https://diabetes.diabetesjournals.org/content/42/2/341.short