RE: Print manuals - keep or drop

Subject: RE: Print manuals - keep or drop
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Tue, 1 Apr 2008 08:20:17 -0400

> -----Original Message-----
> From: Milan Davidovic
> Sent: Monday, March 31, 2008 3:33 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: Print manuals - keep or drop
> I'm not personally familiar with the EU's Medical Devices
> Directive:
> But I'm told by people here at work that the MDD
> requires print manuals, so we have no choice in the
> matter. If your work has to conform to some sort of
> standard or regulatory oversight, it would be worthwhile
> making sure you stay on the right side of it.

... and since David Tinsley's company is based in Canada, it's worth
noting that the Canadian Medical Device Regulations, SOR-98-282 21(2),
require that labeling "be expressed in a legible, permanent, and
prominent manner." Labeling includes the directions for use (i.e.,
manuals), and not just a sticker on the side of a machine.

Happy Tuesday,


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