All posts by altadmin

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.

Schedule a Call

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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!

Schedule a Call

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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!

Schedule a Call

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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 Translations Sponsors the RAPS 2014 Conference

Idem Translations is proud to sponsor the RAPS – 2014 Regulatory Convergence taking place in Austin, TX from Sept 27 to Oct 1. This event gathers regulatory professionals who work in medical device, pharmaceutical, and biotechnology sections. In addition to working with submission and compliance, these regulatory professionals play integral roles in all stages of the health care product lifecycle from development to marketing and post-market surveillance.  This event’s intensive workshops, educational sessions and networking events come together in a program designed by regulatory experts who understand the challenges and opportunities faced by today’s regulatory professionals.  We look forward to seeing you at our booth – number 231.

Idem to participate in the 2014 LocWorld Life Sciences Roundtable in Dublin June 3-6th

In the world of translation and localization, the life sciences sector is different from any other industry because of the unique and specific nature of its requirements. With regulations changing on a continual basis, a premium is placed on quality above all else. For our Life Sciences Business Round Table in Dublin, we are delighted to offer a stellar one-and-a-half day program with a particular focus on the challenges of medical device localization. Life sciences professionals, clients and vendors will be presenting and sharing their thoughts and experiences on specific processes as well as the variety of requirements and challenges at work in the life sciences industry today. Click image below for conference details:

Executive Summary of the Intelligent Content for Life Sciences Conference

Idem’s VP of Quality & Operations, Jessica Alexander, attended the Intelligent Content Conference for Life Sciences and Healthcare May 8‐9, 2014 in San Francisco, California. The conference focused on how professionals in the medical device, pharmaceutical, and healthcare fields can take advantage of advances in content management processes to improve their own content, improve the user experience for their customer base, and reduce translation and localization costs. For a summary of conference highlights please click on the image below.

ICC 2

Idem Translations will attend the 10x Medical Device Conference May 12-14, 2014 in Minneapolis, MN.

Idem Translations will be attending the 2014 Medical Device 10X Conference – An event focused on growth strategies for Medical Device companies. Topics will include:

• What European Reg Changes Mean For Your Business
• Leading Causes of Success or Failure in a Medical Device Start Up
• A Regulatory Primer for MedDev Manufacturing and Operations
• Development Considerations Taken By Successful MedDev Startups
• Extractables and Leachables Testing for Medical Devices

Idem Translations will attend the DIA Global Labeling 2014 Conference in Bethesda, MD April 9-10th.

Idem Translations will be attending the 2014 Global Labeling Conference April 9-10th where regulators and industry representatives will discuss the impact of recent global labeling guidelines and regulations including:

• EU global pharmacovigilance guidelines
• Draft and new FDA guidances
• Plain language initiative in Canada
• Risk management regulations in Japan
• Other emerging labeling guidances (Canada, European Union, Japan, US)

For more information, click on the image below.

DIA2014

Idem Translations attended the ASCPT Conference March 18-22, 2014 in Atlanta, GA

Idem participated in the annual conference for the American Society for Clinical Pharmacology and Therapeutics March 18-22, 2014. The event was held in Atlanta, GA. Over 1,100 scientists, clinicians and educators attended this meeting in 2014 to learn, connect, and network. This meeting is the preferred clinical pharmacology and therapeutics conference.

ASCPT 2014


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