Manual Translation procedure for the translation of manuals into other languages

A

Arie0712 - 2010

#11
Re: Manual Translation procedure for the translation of our manuals into other langua

Hi

Both atitudes mentioned can be acceptable, though starting with the translating experts is seems to be better. having a second look by native speekers such as distributors may have a nother bennefit, as the distributor is familiar with the product and related subject. Second look may turn to a validation report (not verification).
I would like to share with you few understandings I adopt after having some experience:
- When you want to choose translation office, and after you got some
good recommendations, start little and validate its quality.
- Treat documents, which you use to translate, very carefully in terms of
updates, as each update will results in multiple costs for translations (by
the way, for minor upgrades, consider having the support of your
distributors or your native speakers employees).
- Where you don't have local regulation enforecments regarding
labels, and text can be replaced by international icons, don't put text,
so you won't have to stick to translations and/or multiple labels.

:) Arie
 
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Marcelo

Inactive Registered Visitor
#12
Re: Manual Translation procedure for the translation of our manuals into other langua

One thing that need to be kept in mind...manuals and other instructions for use (and markings) contain information for safety (the third level of risk control required by ISO 14971). So, the translations has to keep this intact. So, all translations have to be revised in the risk management process to keep the risks acceptable.

This is not what is generally done today (although i know some manufacturers already do), but will surely be in the future :).
 
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S

SteveK

#13
Re: Manual Translation procedure for the translation of our manuals into other langua

We supply (mainly Class IIa medical devices) outside the UK to markets where English is not the first language. However, we only supply documentation in English e.g. operating instructions (note the devices are not complicated – MDD Annex I section 13.1 indicates”….no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions”, which basically it could be argued they can). Being British, of course, we only (can) correspond with customers who can communicate in English. In submitting a Technical File recently for review, our NB would not close it out (thus far) because they have asked the question “how is the control of translation managed”? We have never (over 40+ years) ever supplied any translations, do not intend to or have been requested to. Therefore we have no procedure in place as part of our QMS.

Do we definitely have to have one - not absolutely clear to me from the MDD etc?

If so, would a having procedure in place saying what we would do e.g. use an accredited service if required be enough, i.e. it could be as short as the ‘Translation’ MEDDEV?

Ta!

Steve
 
K

KAMay

#14
Re: Manual Translation procedure for the translation of our manuals into other langua

Hi SteveK,

Our case is different because we have a class IIb device however I asked our NB did we have to have a procedure in place for translating our IFUs (we had received an 'observation' in our audit that we didn't have any procedure for translating) and also did we need to translate our display and the software.. I received this reply:

According to the Directive the device needs to be able to be used in the country it is supplied to. With regard to [our class IIb device] this would mean that the display would need to be translated as this is a crucial function of its use. If the software is needed for the operation of the device then this would also need to be translated.
I got very stressed out about the translation procedure and did start investigating varying country's local requirements - quite a few of them do actually require you ship to them with translated IFUs - we hadn't been doing that either, not sure how we were getting away with it!

Attached is a table I compiled using all the different data I could find about the issue (for European countries and 'other' countries that we ship to). It is nowhere near definitive and I cannot undoubtedly claim its accuracy although I did try my best!

I think I attached the procedure I wrote somewhere else in this forum hoping for some constructive criticism - I can send it to you if you want it, but we have not been audited since it was written so I cannot guarantee its accuracy! :)

hope this helps.
 

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Rocke

Involved In Discussions
#15
Re: Manual Translation procedure for the translation of our manuals into other langua

Hi,

Maybe things are slightly different for us because we supply IVD's, and the requirements are differentiated between "home-use" devices and "professional use" devises, with much more strict enforcement of translation of instruction fro devices for "home.-use".

We supply to professional users and have translated to the major languages. When approached by a customer (professional users) in a country where we do not have a translated instruction, we ask the customer to verify, that English instructions are acceptable.
So far this has not raised any objections.
 
T

treesei

#16
Re: Manual Translation procedure for the translation of our manuals into other langua

Being bilingual, I have seen many technical translations and have done many. My thoughts are:

1. Definitely have ssomeone who understands the technology/product and is a native speaker review the draft. "Professional" traslation services cannot do a good job if they do not understand the technology and terminology. ISO cert will not help.

2. Understand that no translation is perfect.

3. When possible, add a note that claims that the document that is written with the original language is the "golden standard".
 

sreenu927

Quite Involved in Discussions
#17
Re: Manual Translation procedure for the translation of our manuals into other langua

I feel one of the better ways for translations is:

--Seek Translation Services for doing so
--to verify the correctness and effectiveness, give the task to another cosulting service and ask them to translate back into english.

However, this incurs alot of money!

Regards
Sreenu
 
S

sono_fateh - 2010

#18
Re: Manual Translation procedure for the translation of our manuals into other langua

It sounds logical to get the translation first done by the proffessional translators (with ISO certified translation agency, employing native speakers) and then get that validated by the native distributor of your product or a native professional...
 
S

sono_fateh - 2010

#19
Re: Manual Translation procedure for the translation of our manuals into other langua

--to verify the correctness and effectiveness, give the task to another cosulting service and ask them to translate back into english.
I would think, this not only incurs a huge budget for Translations , but also time and effort for tracking and analysis.

If we have the signatures of the translators and validators, then we are safe.. however the correctness of the translators can be judged only by a native- professional who deals with your medical device and having his validation is more worth than having a validation certificate from an ISO certified ompany, cuz of his direct experience with the device.
 
V

Vlcekad

#20
Re: Manual Translation procedure for the translation of our manuals into other langua

Hi everybody,

I am working on SOP for traslation IFU - medical devices.
I chosed a reputable translation provider, but I am having problems how to define metrics for acceptance - quality measurement of translation.

Provides has ISO 13485, ISO 9001, translated according to ISO 15038. We will build glossary of the most important or defined (ie labeling symbols) terms. They will provide proof of comptented for translators - acording to ISO 15038.

But - this still does prove, that the actual translation is correct, or that it containes only acceptable errors that have no influence on meaning.

I would like to use our distributors as subject matter experts, and ask them to look for defined types of errors - grammar / stylistic / medical or technical - and then assess if the error is / may be / is not influecing meaning. And then set a acceptance level.

I would like to ask - how do you evalueate the quality of translation, and what is your acceptacne criteria?

Thanks!
Adam
 
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