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Been preaching #1 for 10+ years. Assume its going to be a 510K or GXP. Most of the requirements for that are just good practices anyway.

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If you know Dave Taht, h'e working on LibreQoS.io, which I've been writing about in the CACM. I think it's fair to say they are trying to execute on "scale and adoption across industries and emergent technology capabilities" (:-)) You might want to have a peek.

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