Regulatory Open Forum

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  • 1.  Software Translation

    Posted 30-Nov-2016 16:36

    I need some help regarding translation services.  I'm working with a client preparing a software only device, Class I EU (for now) and Class II US.   The software is used only by healthcare professionals.  We will require translation to support registration in a few countries.

    How does one go about translating the actual software?  Does the translation service work with the programmers? 

    Has anyone worked with a great translation company that they can recommend?

    ------------------------------
    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com
    ------------------------------


  • 2.  RE: Software Translation

    Posted 01-Dec-2016 03:07

    Dear Karen

    The easiest is (based on my experience) if the software programmers extract the readable text from the actual software and provide it to the translator. Often this can be done in a format that allows the programmers to copy in the translated text in an easy way later on which saves time (and costs). Alternatively, if the detailed text is part of a requirements specification (which often is the case), this document may be submitted instead. The advantage is that the text is often put into context with its use which may be helpful for the translator.

    Several of our clients (pharma and medtech) work with one of the two following translation agencies and are very happy with the collaboration:

    - mt-g: www.mt-g.eu/en/
    - Lionbridge Technologies: www.lionbridge.com/

    Please note that it is a common misunderstanding that for most countries in Europe it is sufficient to "offer" English as the only language in case the software (or the medical device in general) is for professional use. Almost all national legislation requires the accompanying documents to be provided in the official language(s) of the respective country.

    Hope this helps.

    Cheers, Beat

    ------------------------------
    Beat U. Steffen
    Founder, CEO
    confinis ag
    Duedingen
    Switzerland



  • 3.  RE: Software Translation

    Posted 02-Dec-2016 16:34

    Thank you very much!

    Karen

    ------------------------------
    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com



  • 4.  RE: Software Translation

    Posted 01-Dec-2016 06:52

    Jack Fischer at Morningside Translation Services can fulfill all your needs. We highly recommend!

    JFischer@MorningTrans.Com

    ------------------------------
    Rene' Hardee
    Regulatory Affairs Specialist III
    Sun Nuclear Corporation
    Melbourne FL
    United States



  • 5.  RE: Software Translation

    Posted 02-Dec-2016 16:35

    Much appreciated!

    Karen

    ------------------------------
    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com



  • 6.  RE: Software Translation

    Posted 01-Dec-2016 07:44

    Hi Karen

    The software is only translated for the GUI portions. The strings of software found in the GUI are typically sent to a translation house in a CSV or Excel format, translated, certified and sent back in the same format. After that the software team needs to deploy this is a test environment to be sure through V&V that the translated text fits correctly and completely in the intended location.

    I know many do it, but Sajan here in River Falls does this and is a large translation player. 

    Let me know if you need more info, I will consult one of my software engineers.

    Good luck!

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC
    centaurconsultingllc@gmail.com






  • 7.  RE: Software Translation

    Posted 02-Dec-2016 16:33

    Thank you!  I expect that they'll be ready in 4-6 weeks.  Hope to be in touch soon.

    Karen

    ------------------------------
    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com