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How to Get Localization and Testing for Medical Devices Done Right

The medical device field is a unique and specialized industry that must meet many requirements in order to produce these critical healthcare products. The software for medical devices must undergo strict testing before it’s released due to the nature of the product. If the software is localized for global markets, it also must undergo strict testing to ensure that it’s linguistically, cosmetically and functionally ready for an international audience.

As part of our ongoing efforts to better support our customers’ efforts to synchronize and improve their agile software development, we recently had the pleasure of announcing a partnership with QualiTest, the world’s second largest pure-play software testing and quality assurance company. We feel that this partnership is a great fit since both of our companies support medical device, healthcare and software development companies with their testing, quality assurance and localization solutions.

So if you are involved in the localization or software development process in the medical device industry, you don’t want to miss our next webinar. QualiTest and Net-Translators will present an hour-long, complimentary, online session entitled “How to get localization and testing for medical devices done right” on Thursday, February 23, 2017 at 11:00 EST.

 

 

Let’s take a quick look at some of the common issues, which we’ll discuss during the webinar.

Challenges with Developing Software for Medical Devices

The medical device industry faces numerous challenges, with potentially long product development cycles and critical medical software to create. Medical software must undergo a detailed development process and comprehensive software testing and validation in order to meet safety and compliance requirements. Some of the challenges with medical software design include compliance and design, security, integration and usability.

In addition to the software, there’s a huge amount of material that accompanies medical products, from customer-facing content such as software, marketing materials and instructions to product-related content for regulators such as clinical trial paperwork and quality management system certifications.

Localization and Testing Requirements for Medical Software

In addition to all the requirements to produce a medical device in English, there’s a whole other layer of complexity in taking that product to a global market. In order for companies to export their products to global markets, they must follow a variety of regulations, which vary based on the individual country.

One of the core requirements is that product content needs to be translated into the native language(s) of the country. For a software product, this not only includes the user interface but also online help, release notes and supporting documentation.

In order to produce high-quality global content, you need to engage a language service provider (LSP) with a specialization in software localization and testing for the medical industry. Since regulations vary by country, you want an LSP who can navigate these waters for you. The LSP must place a very high priority on quality given that the product involves health and it must go through rigorous software testing. You also want to ensure that the LSP uses native-speaking, experienced translators.

Getting Localization and Testing for Medical Devices Done Right Webinar

With Net-Translators’ strengths in localization and multilingual testing services, and QualiTest’s expertise in medical and healthcare systems, we look forward to sharing our knowledge and experience during the webinar. Nausheen Sayed, VP of US-UK Knowledge and Innovation at QualiTest, joins me at this webinar as we’ll talk about some of the challenges working with localized medical products and provide some lessons learned. We’ll also discuss:

  • Best practices and pointers
  • Efficient management and maintenance of Clinical and Patient Test Data
  • Localization infrastructure and translation management
  • We will help you analyze your testing and localization solutions to detect your omissions and improve your overall strategy

I hope you can join us for this webinar and we look forward to “seeing” you soon!

 

Testing for Medical Devices Done Right

About the author:

David Sommer

For roughly a decade I have been helping people around the world gain access to the world's leading products and services by making them accessible in their native language. My previous experience with a national standards institute taught me how to achieve quality and present the results.  Having started at Net-Translators as a Localization Project Manager winding up a Senior Localization Manager, and finally to my current position as Director of Strategic Operations, I have learned much about the industry, but more importantly, I have focused continually on how I can improve processes and deliverables in a theoretical as well as practical manner. I am constantly on the lookout to learn more about our industry and implement new ideas.

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