[ska]

Good stuff! Device projects typically take a while. Industry average for a device like this is something like 3-5 years start to finish, so you are right it's pretty quick (although other ventilator efforts have been similarly fast - it's almost like there was extraordinary motivation).

I've seen 18 months before, but that was primarily software. I think the FDA clock on evaluation is 120 days now, that's after all the i's are dotted and t's crossed. EU MDD/MDR is similar, iirc.

Congrats on getting something together quickly!