Dear Idem: What do we do if the user interface on our medical device isn’t translated?

Dear Idem Translations,

We plan to translate the user interface for our device, but we aren’t ready to tackle this  in the immediate future. We have an opportunity in another market outside the U.S. right now, and although the UI isn’t translated, we will translate the instructions for use. Will this pass muster with the notified body? Do you have recommendations for how to handle?  

Translating software strings can be a complex process, especially if the software wasn’t developed with translation in mind (but that’s a separate topic for another time). It’s a good sign, though, that Engineering is thinking long-term about non-English users.  For compliance in your immediate plans, it’s critical that all actionable instructions are clear and easy to follow in the IFU, even if the user is operating with an English screen they cannot read.

There are several ways you can tackle this problem. In the screenshots you replicate in the IFU, you can use indicators such as arrows, callouts, or different colors to draw the user’s attention to actionable elements, so long as they don’t detract from overall usability. Too many arrows cluttering the instructions could confuse the user, so use them sparingly.

In the text of the IFU instructions, you can also embed on-screen commands (in English) while providing translations directly after. For example, if your instructions in English read:

Tap and hold the ‘Open’ button.

your instructions in French could read:

Appuyer et maintenir le bouton ‘Open’ (Ouvrir).

You might also a reference table for on-screen text. This table would contain terms used in the English GUI in one column and the translated terms in the column directly beside it.

Most importantly, though, talk to your translation provider to create a strategy that will work for your specific software and the content of your IFU.  They’ll be happy to help you optimize.

Contact us – we’ll step you through the process!

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