RE: RE: Laws Requiring User Documentation

Subject: RE: RE: Laws Requiring User Documentation
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Wed, 9 Nov 2011 15:45:03 -0500

You can't back up your claim that "documentation is legally required"
because isn't true - or rather, it's too broad to be true. The advice to
check with a regulatory professional is wise.

It's also a good idea to review the difference between standards and
regulations. ISO can't send you to jail, but FDA can!

-----Original Message-----
From: Nancy Allison
Sent: Wednesday, November 09, 2011 3:18 PM
Cc: techwr-l -at- techwr-l -dot- com
Subject: Re: RE: Laws Requiring User Documentation

In case this additional information is helpful, the context of my
question is that at a recent conference I heard someone saying that in a
pinch he would release his company's products without any documentation
at all.

I wanted to say "But documentation is legally required!" but knew I
couldn't back up the claim...

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