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Are you working with a test house? They can really help pin down issues quickly.

Sounds like a fun project!

Yes we are :) The first days were fun. Then the french government pushed the project. Challenging, crazy, but exhausting. 25 days without coming back home! Then the lockdown did the job, and the project was not so urgent, so the ANSM (french equivalent of US FDA) was not so in a hurry. And now it seems to take ages for us between two administrative steps, but it is still fast for ANSM. Development of a ventilator take normally a few years!

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!

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