Regulatory Open Forum

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  • 1.  Translation Service Provider

    Posted 11-Aug-2015 16:18

    Dear Regulatory Colleagues,

    I am looking for a translation service provider.  Could you recommend one based on their translation accuracy, on-time delivery, reasonable charge and customer service?  Any other input is certainly appreciated.  Thanks for the recommendation in advance.


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    Dawn Chang
    Regulatory Affairs
    Los Altos, CA
    United States
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  • 2.  RE: Translation Service Provider

    Posted 11-Aug-2015 17:24
    Dawn,

    If you can provide a little bit of description (e.g., scope of the work; what kind of technical documents to translate into what/how many different languages), you may get a targeted response in my opinion.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 3.  RE: Translation Service Provider

    Posted 12-Aug-2015 13:24

    Hi David,

    Thank you for your questions.

    In terms of the scope of work, the translation service provider will mainly be translating labeling pieces, or patient consent forms.  Languages involved will mostly be the European languages.

    Based on your expertise, as I qualify the translation service provider, what are the typical certificates I should be looking for, e.g. ISO 13485, ISO 9001, EN 15038?  Is there anyone of these certificates that is a must? Also, if the provider is certified to ISO 13485, is there any difference or preference between ISO 13485:2003 vs EN ISO 13485:2012?

    Also, from the quality system standpoint, should the translation service provider be considered as critical level supplier which impacts the safety and functioning of the product, or is it sufficient to treat them as just a normal level service provider?

    Lastly, is the translation service provider subject to Notified Body unannounced audits?  If it is, should there be a clause in the Service Agreement related to unannounced audits?

    I appreciate your time in advance.

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    Dawn Chang
    Sr. Regulatory Affairs Manager
    Kyma Medical Technologies, Inc.
    Los Altos CA
    United States
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    Original Message


  • 4.  RE: Translation Service Provider

    Posted 12-Aug-2015 15:12
    Dawn,

    Thank you.  Now I would recommend you establish and maintain an SOP for translation including your firm's criteria of qualification.  Based on your criteria, you may qualify few. Based on the list, you may choose to work with. 

    To build your criteria, you may consider these factors including, but not limited to, 1.) one who is ready, willing and able to do a forward/backward translation; 2). Two forward translations by two independent translators; 3). native speakers of the target languages with a college-level degree with some technical experience/proficiency, etc.   

    Please be noted that presenting certificates (ISO 13485 or others) don't always mean they are better as sometimes, they can be worse compared to those not having such certificate. 

    ISO 13485 or EN ISO 13485:2012 are identical as far as normative requirements are concerned.  For your case, EN ISO 13485:2012 would be better if you want to force yourself to select unless it is justified or justifiable otherwise.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 5.  RE: Translation Service Provider

    Posted 12-Aug-2015 14:19

    I highly recommend a local (to you, in Palo Alto) provider, IDEM Translations.  Fast, accurate, moderately priced; I use them for all my translations.  www.idemtranslations.com/ 

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    Peggy McLaughlin
    Menlo Park CA
    United States
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    Original Message


  • 6.  RE: Translation Service Provider

    Posted 12-Aug-2015 16:35

    Thank you Peggy for your recommendation.  And thank you David for sharing your expert knowledge.  I appreciate it.

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    Dawn Chang
    Los Altos CA
    United States
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    Original Message