FDA-conform validation - any hints?

Jim Drash jim.drash@gmail.com
Mon Apr 11 15:00:00 GMT 2005


On Apr 11, 2005 9:48 AM, Jan Schormann <Jan.Schormann@brainlab.com> wrote:
> 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?
> 

FDA Validation in your case is about telling how you do your builds
and showing that you follow what you say.  I am not sure what you are
looking for.

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