Regulatory Open Forum

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  • 1.  Recommendations for translation services

    This message was posted by a user wishing to remain anonymous
    Posted 19-Apr-2021 17:54
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    Can anyone recommend a company that provides translation services for user manuals and user interfaces for a complex medical device that is intended for patient monitoring in the intensive care environment?

    Many thanks!


  • 2.  RE: Recommendations for translation services

    Posted 20-Apr-2021 09:02
    Good Morning Anonymous,

    I have used both Idem (https://idemtranslations.com/) and Morningside Translations (https://www.morningtrans.com/) in the past and had good experiences with both of them.

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    Keri Froese RAC
    Manager Compliance & Regulatory Affairs
    Healthsign
    Ottawa
    Canada
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  • 3.  RE: Recommendations for translation services

    Posted 20-Apr-2021 11:55
    Hello,

    I have used Idem Translations (https://idemtranslations.com/) exclusively throughout my 25-year career in medical devices. I have referred them to many companies and have only heard glowing reviews. If you have specific questions, please feel free to contact me.

    Julia

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    Julia Brown
    Sr Manager, Regulatory Affairs
    Brisbane CA
    United States
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  • 4.  RE: Recommendations for translation services

    Posted 21-Apr-2021 01:58
    I've had luck with Zebra Translations in the past for medical device labeling: www.zebratranslations.uk 

    Good luck!

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    Rachel Leahy RAC, PhD
    Edgewater MD
    United States
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  • 5.  RE: Recommendations for translation services

    Posted 21-Apr-2021 02:37
    Are those translations companies (if so crucial) than listed as critical suppliers ??

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    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
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  • 6.  RE: Recommendations for translation services

    Posted 22-Apr-2021 09:36
    Hello, I recommended Argo Translations https://www.argotrans.com 

    They are highly knowledgeable of regulations and have a very tough vetting process for their translators.  Some are even retired medical doctors.

    And for sure, whoever you pick needs to be on your supplier list.

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    Michelle Lott RAC
    Principal & Founder
    Lean RAQA Systems, LLC
    michelle@leanraqa.com
    ------------------------------



  • 7.  RE: Recommendations for translation services

    Posted 27-Apr-2021 08:22
    We utilize Intransco for our IFU and insert translations​. They are always responsive and we've had success with them.

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    Stacey Benser
    Senior Quality/Regulatory Manager
    HR Pharmaceuticals, Inc
    York PA
    United States
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