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RE: FDA-conform validation - any hints?
- From: "Gary R. Van Sickle" <g dot r dot vansickle at worldnet dot att dot net>
- To: <cygwin at cygwin dot com>
- Date: Mon, 11 Apr 2005 12:46:18 -0500
- Subject: RE: FDA-conform validation - any hints?
> -----Original Message-----
> From: firstname.lastname@example.org
> [mailto:email@example.com] On Behalf Of Jan Schormann
> Sent: Monday, April 11, 2005 8:49 AM
> To: firstname.lastname@example.org
> Subject: 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!
What Jim said, and also the FDA tends to be more concerned with test
processes and results.
Gary R. Van Sickle
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