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FDA-conform validation - any hints?


Hi all,

my company develops medical devices, so we must fulfill
the FDA (U.S. Food & Drug Administration) regulations.
As we are using Cygwin in our software build chain
(especially for GNU make and bash), we need to explain
what makes us so confident.

I've scanned the archives with no satisfying outcome, so ...

Has anyone ever tried this before?
Do you have any hints?

Thanks all!
	Jan.



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