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  • 1.  Translation by Distributor

    This message was posted by a user wishing to remain anonymous
    Posted 13-Aug-2019 16:52
    This message was posted by a user wishing to remain anonymous

    All,

    I have a few questions for you regarding translation.

    My company wants translation of our IFUs and software to be completed by our distributor. We would put the onus on the distributor to identify a reputable company to complete this task or have the distributor complete this themselves. I am arguing to have a translation company complete this work and provide certification that the translations are correct.

    Has anyone encountered this situation?

    Additionally, executive management seems to believe that the translation company needs to be in the field for which our device is intended - nuclear medicine. I believe a translation company that specializes in translating scientific information is sufficient. I am currently losing this argument - any suggestions?


  • 2.  RE: Translation by Distributor

    Posted 14-Aug-2019 05:16
    Hello,

    Just a word of advice: don't.  As the legal manufacturer and manufacturer of the medical device, the responsibility of the device, safety, and performance is your company, not the distributor.  I can give you a personal example you can go back to your management.  We had an IFU we let the distributor translate.  The translation was not correct.  A patient got hurt.  We did a recall.  Now, the distributor translated the IFU themselves, but giving a distributor the responsibility to translate through a reputable company.  Why not your company just do this?  And please do not say cost.  That would be the worst reason to not have the responsibility for the translation.  If you do have the distributor translate the IFU, then I would recommend having this verified by an independent company of your choosing and make sure the translation is correct.  Generally, you can find translation companies working in the medical device field, so they can be used to the technical terminology.  But this is another reason you should translate the IFU, because you can work directly with the translation company if there are uncertainties on their part about phrases or context of IFU section..

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Translation by Distributor

    Posted 14-Aug-2019 10:13
    Dear Anom,

    When reading your post, two thoughts immediately popped into my head:  validation and competence.

    Whether you obtain a "certification" of the translation or not, you will be required to demonstrate the translation process is validated.

    Whether you use a nuclear medicine specialist or you use a general scientific translator, the person will need to be competent.

    You will want to be sure to discuss these two items with whomever you choose for translations.  This could be a part of your supplier evaluation file.

    Good luck,

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    John Beasley, RAC (US)
    MedTech Review, LLC
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    Original Message


  • 4.  RE: Translation by Distributor

    Posted 16-Aug-2019 07:34
    Hello,

    after working 25 years in the medical device and pharma translation industry, both on client and translation provider side, I can say with absolute certainty that for translating IFUs, patient, physician, technical manuals and any other type of highly regulated documents, you will need people who are trained to do so and have the experience to do so. This expert should have a degree in linguistics in one of the target languages in which we translate and in-depth experience in particular subject matter expertise at minimum. For example: medical devices -> cardiology --> defibrillators, etc.
    Moreover now, with the implementation of the new MDR/IVDR there is much more scrutiny on the proper use of a device, more accountability of the manufacturer during the entire life-cycle of the device, so also past market release. This all leads to a significant growth of complex, technical documentation that needs to be translated for products that have been reclassified to a higher-risk category.
    Let us not dismiss the good that a distributor can do. In my past experience, we have worked successfully with in-country distributors, who in the end knew their target market best and were able to help us "localize" the translations and make them appropriate for the given market.

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    Clio Schils
    Global Director of Life Sciences
    Hackensack NJ
    United States
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    Original Message


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