FDA-conform validation - any hints?

Jan Schormann Jan.Schormann@BrainLAB.com
Mon Apr 11 14:08:00 GMT 2005


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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