Turkish Requirements - Does the Software need to be translated?

#1
hELLO?
we did register our MD in turkey, we are a french manufacturer and I was wondering if the software of our medical device must be translated in turkish? the MD is ce marked, and the user manual of the device itself not the software was translated.
thanks
 
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Benjamin Weber

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#2
I think this depends very much on the intended users: Are they lays (not specially trained, maybe used in private/homecare environments,...) or professionals? Do you think, the turkish users will be able to understand the language you have currently implemented (I assume Frensh or maybe English)? Ideally you should consider this within the usability process with turkish users.

I hope this helps.
 

chris1price

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#3
I would suggest performing a risk assessment. as the previous respondent said, consider the abilities of the users, the likelihood of mistakes occurring, the severity/harm such mistakes could have, the effect on the product and your company from such events; as well as the regulatory requirements in Turkey together with any other factors that are relevant. This should guide you.

FYI, in my past experience, we made Turkish translations of all IFUs and labelling, and eventually the software itself. Your product may be different.
 
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