Re: Manual fail...

Subject: Re: Manual fail...
From: Milan Davidović <milan -dot- lists -at- gmail -dot- com>
To: Dan Goldstein <DGoldstein -at- riverainmedical -dot- com>
Date: Mon, 11 Jan 2010 09:27:19 -0500

On Mon, Jan 11, 2010 at 9:17 AM, Dan Goldstein
<DGoldstein -at- riverainmedical -dot- com> wrote:
> If J&J's initial requirement had been something
> like, "the product shall have a 40-page manual," the PMA review for the
> stent would have lit up a few red lights at the agency.

J&J mustn't have much for a quality check before releasing the
labeling, though -- and that might show up if there's ever an audit.

--
Milan DavidoviÄ
http://altmilan.blogspot.com
http://delicious.com/milan_davidovic
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Follow-Ups:

References:
RE: Manual fail...: From: Fred Ridder
Re: Manual fail...: From: beelia
RE: Manual fail...: From: Dan Goldstein

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