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How do the open source medical equiptment projects jibe with all of the FDA regulations?

I've always wanted to start an open source ultrasound project but I figured there would be too many hurdles.

Don't target medical markets. Target weld inspection.

Exactly. I work in medical hw/sw and I can tell you the amount of bureucracy is insane and everything is orders of magnitude harder than any non-regulated business. Open Source itself is not really a problem, we use a lot of it (os, libs, etc.).

But those projects listed OpenEEG, the one for anesthesia, etc are targeted as medical devices (I think). Are they just operating under the radar?

They are targeted towards hobbyists...

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