RE: Manual fail...

Subject: RE: Manual fail...
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Mon, 11 Jan 2010 09:17:00 -0500

Bee's hypothesis (or something like it) is more likely. Nothing in FDA's
regulations for medical devices would guide a manufacturer toward a
specific manual length. 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.

> -----Original Message-----
> From: beelia
> Sent: Sunday, January 10, 2010 4:27 PM
> To: Fred Ridder
> Cc: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: Manual fail...
> I have a different theory (for the second example). The
> writer may have been using a tool like inDesign and was told
> that the result would be printed locally, double-sided and
> saddlestitched. He or she probably didn't know how to revise
> the 2-up or 4-up format to get all the pages to print
> consecutively with the correct numbered page on the other
> side, and as a short (sloppy) cut, put in all those blank
> pages to provide the correct number of folded-over pages.
> Just a theory, not an excuse.
> Cheers
> Bee
> 2010/1/10 Fred Ridder
> >
> > I suspect that it is significant that these manuals are both for
> > medical (i.e. highly regulated) products, and that in both
> cases the
> > total page count is exactly 40. I'm hypothesizing that at
> some point
> > in the product's regulatory history it was established that the
> > product shall have a 40-page manual, and that is what the
> company is
> > delivering. Our healthcare dollars hard at work...
> >

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RE: Manual fail...: From: Fred Ridder
Re: Manual fail...: From: beelia

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