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Idem Translations is a top-ranked global translation provider countless life science companies have come to rely on for translation expertise and ISO-certified processes that guarantee quality, consistency, and trust.

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Translating Instructions for Use: Read This First

Your next device or therapy will be available for commercial use in markets outside the U.S. and you have been tasked with finding someone to translate the Instructions for Use. You know you need a professional translator whose work will pass regulatory requirements, so you do a little research online and find a vendor with a decent website and respectable client roster. Great!  Before you call, prepare yourself to provide key information that your new translation vendor will need.

Do you know which languages you’ll be translating into? You may only want to translate one or two foreign languages at initial launch, but have you considered subsequent version releases that will include more languages? This is important, because it will help you determine the size and format your IFU should be.

Foreign languages expand with translation – a standard rule of thumb is about 30%. Your printer can help design the appropriate format, such as map fold or booklet, and provide specifications.

Make sure the source file and specifications are available to the translation vendor at the onset of the project; a pdf is a good reference document, yet it won’t help with multilingual translation and lay out.  It may seem counterintuitive to include your printer in translation issues and yet they go hand in hand.

By planning a few key elements before actual translation takes place, you can save time and money.

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Translation versus Localization – What’s the Difference?

If you’re new to translations, you may hear the term localization bandied about. Perhaps you’ve called a translation services provider and explained your project needs, and they launch into a description of the ways in which they’ll localize your files.

You’re a clinician. References to translation and localization have wholly different meanings in your world. So, what’s the difference?  Simply stated, translation is the process of changing words from one language to another.  If you need a document translated from English to German, that’s known as translation.  Localization is more like cultural adaptation. Beyond the primary meaning, localization also addresses norms and style that are familiar to the local population.  Date formats are a classic example because they can be a major source of confusion between Americans and other nationalities: at best they are a headache, at worst they introduce patient risk, especially with respect to software localization on medical devices and applications.

Other terms include internationalization, which refers to the upstream process of planning to ensure content can be translated or localized without disrupting functionality. All of these activities can be couched within a larger framework known as globalization, which represents the way that people, company, and governments interact around the globe. If you’d like to learn more, contact Idem today for a free consultation. We’d be happy to help!

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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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Quick Facts About Idem Translations

Translate your content using specialist medical linguists. Below is a quick overview of Idem’s services for companies in the medical device and pharmaceutical industries. We offer comprehensive translation services, including back translation, reconciliation, linguistic review, quality assurance, DTP and more.

Idem Proud to Be a NCC ACRP Sponsor

This year, Idem continues our sponsorship of the Northern California Chapter of the Association for Clinical Research Professionals. The NCC ACRP has been serving the California Bay Area and Sacramento since 1999, providing opportunities for professional development and networking. It was honored as the ACRP Chapter of the Year in 2012.

Idem is committed to doing our part to ensure patient safety in clinical research, the front line of innovation. We provide timely and clear informed consents to patients in their own language and immediate access to accurate trial data for study sponsors.


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