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Comment by ska | Hacker News Reader

I think the problem OP is referring to is that if you were proposing this design for a approved medical device for use in say US & EU, you might have trouble passing e.g. 60601 because of the communication channel. I haven't looked over the design in detail but EMI etc. can be quite tricky to manage in this sort of device.

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You're right. We will see. EMC tests are part of our program.

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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