Capabilities

The European Medical Device Directive requires that software/UI be localized as part of the product labeling requirements. Our experience with software localization has enabled us to be successful in supporting our client’s efforts to fulfill this requirement. Drawing on the proprietary Multilingual Compliance Process, we localize products quickly, expertly and within the complex framework of global regulations. ForeignExchange has extensive expertise in localizing user interface content for a variety of medical devices.

Because of the unique development environment required for our medical device clients, we deal with a variety of file formats, including:

• Externalized string resources in .rc, .xls, or .txt format
• Externalized .xml, .html, json, .yaml or strings in Word format
• iOS/Mac and Android string formatsBinary files such as .exe, properties files and resource bundles.
• .net development platform
• Java, javascript, asp, C+ and C++
• Translation file formats such as .ts, .po, .wxl, .xlf (xliff), etc.
• Custom file types

We deploy standard industry tools to best handle the file formats delivered and maintain the integrity of the source files. We work with our clients to understand how their strings are being used, compiled and displayed, to develop a sound strategy for rebuilding and testing the localized version.

Some of the issues we typically account for are:

• String concatenations
• String length limitations
• Use of variable or generated text
• Alphabetization and sorting
• Hotkeys or other special key functions that need to be duplicated in the foreign language

Testing and validation typically covers a linguistic review in context. This can sometimes be difficult to do remotely on a medical device. In situations where a remote test environment is not feasible, we work with our clients to provide on-site linguistic testers..

Testing at the ForeignExchange operational site: The technical lead will work with the client software engineer to define testing requirements, set up and develop a translation test plan. The test environment is then set up at our operational site where local linguists are brought in to perform the linguistic testing. Alternatively, should requirements allow, ForeignExchange can set up remote testing with our linguists where they can access the simulated environment from anywhere in the world.

Testing at the client site: For many of our medical device clients, it is impossible to replicate the environment outside of the client site. In these cases, ForeignExchange provides linguists onsite at the client facility to perform the linguistic testing. In addition, we work with our clients to set up remote access so that testing can be performed by our linguists from any location in the world. The entire software localization process is lead by our experienced, professional software localization engineering leads.

ForeignExchange has experience working with most industry-standard operating systems such as Windows, Mac OS, and Linux. ForeignExchange’s technical team also works with custom software and operating systems for some of our largest clients.

Many of our clients in the medical device field have developed custom applications for their software. In these cases, our technical team works closely with the client representative to develop tools and processes to integrate with our client’s preferred tools.