Medical Device Software Translation Requirements

[GPjeri]

I'm looking for a good source or two for various country software translation regulations/requirements. IFU's are no issue but when it comes to software, even our NB and Authorized Rep are not a good source. I've run across subtle differences such as only safety info needs to be translated, or only screen shots need to be translated. Any help is greatly appreciated.

Thank YOU !

 

[sreenu927]

Hi,
I am hopeful that the attachment is helpful.

Regards,
Sreenu

 

[GPjeri]

Thanks!!! May I ask where you got your info on software?

 

[sreenu927]

I remember somewhere from this forum itself!!

-Sreenu

 

[patdub]

According to the guideline from EDMA (European Diagnostic Manufacturer Association) the translation of software screens is not mandatory except when these screens are handling critical safety warnings. Often however it is a market advantage to have screens translated because in some countries customers do not easily accept to work with another language then the local language.

 

[sagai]

I am wondering than how the risk related to the non translated screens can be mitigated ...

 

[GPjeri]

We mitigate by creating Quick Reference Guides in the local language and we provide on-site training with our proficieny panels. Most of the time the professional labs we sell to understand/read English. In most cases our ops manuals (hard copy or ecopy) are translated as well. And of course our PI"s are translated.

 

[sagai]

I would not be happy if me our any of my relatives should have been treated with a medical device user interface speaking Chinese regardless the staff trained well how to use it. regards
Szabolcs