Translation of IFUs and software by Distributor

tebusse

Involved In Discussions
#1
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?

Best, Tonia
 
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shimonv

Trusted Information Resource
#2
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?
While you are the legal manufacturer you bear the responsibility for translations and this has to be done following your procedures.
It's odd that you should outsource the entire process to a distributor; they usually help but not lead.
Also, if you are translating the software it has to go through software testing procedures in accordance with your SOPs.


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?
Best, Tonia
From my experience, a company that specialises in scientific information should be okay. You would be hard pressed to find a translation agencies that 'specialises' in nuclear medicine. Besides, after translation you should do translation verification; the verification should be done by an individual who is a subject matter expert.
 
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