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-----Original Message-----
From: techwr-l-bounces+ccardimon=m-s-g -dot- com -at- lists -dot- techwr-l -dot- com [mailto:techwr-l-bounces+ccardimon=m-s-g -dot- com -at- lists -dot- techwr-l -dot- com] On Behalf Of Gene Kim-Eng
Sent: jeudi 12 janvier 2012 14:38
To: Paul Goble
Cc: TECHWR-L
Subject: Re: FDA (b)anality
You have more imagination than I do. Short of sharpening the edges of the CDs and throwing them as ninja weapons or scattering them on a wet floor to act as substitutes for banana peels, I can't think of any way you could put anyone in jeopardy from software without first installing it into a "device."
Gene Kim-Eng
On Thu, Jan 12, 2012 at 11:06 AM, Paul GobleI haven't yet worked on FDA-regulated medical devices, so I'm curious. It
> probably isn't critical in this case, but I can imagine circumstances
> where using only the official wording could in fact place the user or
> patient in jeopardy.
>
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