FDA and translations (was How do you ensure the quality of translations)

Subject: FDA and translations (was How do you ensure the quality of translations)
From: Deborah Hemstreet <dvora -at- tech-challenged -dot- com>
To: Dan Goldstein <DGoldstein -at- riverainmedical -dot- com>
Date: Mon, 27 Jul 2009 11:30:11 -0400

Hi Dan,

I quite agree with you there. When I was managing translations for a
medical device company, reverse translation was never considered.

I was merely pointing out that the use of this method is not as
clear-cut as it appears.

By the way, I'd be interested, you mentioned FDA. To the best of my
knowledge, there are no requirements per se regarding translation (from
the FDA). Has that changed? If so, could you point me to the link on
their site to read up about that?

I know that the EU and individual countries have requirements, but was
not aware the FDA had started looking at translations of stuff... or is
it only pharmaceuticals? We were dealing with medical devices.

Inquiring minds want to know more!

Thanks!

Deborah

Dan Goldstein wrote:
>> -----Original Message-----
>> From: Deborah Hemstreet
>> Sent: Monday, July 27, 2009 11:03 AM
>> To: Dan Goldstein
>> Cc: techwr-l -at- lists -dot- techwr-l -dot- com
>> Subject: Re: How do you ensure the quality of translations?
>>
>> ... You might want to check translation discussion groups on this
>> issue. I used to be involved with one a few years back, but I
>> no longer have the link. Still, this is one method that,
>> while controversial, is surprisingly used quite often...
>>
>>
>
> I think we'll stick with our existing method, since both we and FDA are
> comfortable with it. In all things regulatory, we strive to avoid
> controversy. I'll bet the same goes for the pharma and aviation tech
> writers on TECHWR-L...
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Free Software Documentation Project Web Cast: Covers developing Table of
Contents, Context IDs, and Index, as well as Doc-To-Help
2009 tips, tricks, and best practices.
http://www.doctohelp.com/SuperPages/Webcasts/

Help & Manual 5: The complete help authoring tool for individual
authors and teams. Professional power, intuitive interface. Write
once, publish to 8 formats. Multi-user authoring and version control! http://www.helpandmanual.com/

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Follow-Ups:

References:
How do you ensure the quality of translations?: From: Boudreaux, Madelyn (GE Healthcare, consultant)
Re: How do you ensure the quality of translations?: From: Dossy Shiobara
RE: How do you ensure the quality of translations?: From: Dan Goldstein
Re: How do you ensure the quality of translations?: From: Deborah Hemstreet
RE: How do you ensure the quality of translations?: From: Dan Goldstein

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