Medical device manufacturers face many challenges when it comes to localizing and testing their medical products. For example, how do you build in enough time for all the different kinds of tests that can be conducted before releasing a product? I had the pleasure of discussing this and other challenges as well as solutions with our partner QualiTest, a software testing company with a specialization in medical device testing, during a webinar called, “How to get localization and testing for medical devices done right” on Thursday, February 23, 2017. I invite you to view the recording of the webinar right below:
In this blog post, I’ll talk about a few of the challenges and solutions that we discussed during the webinar.
Each Country Has Its Own Requirements
One of the challenges for medical device manufacturers is that the process for selling products into a global market varies by country. Businesses must meet each country’s requirements before they can sell products into a country. And to top it off, the requirements aren’t always straightforward or consistent.
For example, the Medical Device Directive 93/42/EEC provides the requirements for medical device manufacturers to sell their products in Europe. A product must have the CE mark on it before it can be sold in Europe. One of the many requirements for manufacturers is that the product content needs to be translated into the native language(s) of the country. However, it isn’t always clear what that means because there can be different requirements for different categories of content or user type and some countries require more than one language. For example, Switzerland requires French, German and Italian.
As a language service provider specializing in the medical industry, we have extensive experience navigating country requirements and can help you determine what’s required for your business situation. Since regulations vary by country, you want an LSP who can navigate these waters for you.
Process and Tools Strategy
There are so many types of content that may need to be translated, from customer-facing content like user manuals, marketing materials and online help, as well as product-related content for regulators like clinical trial paperwork, quality management system certifications and studies. In addition, this content may come in all forms like documents, XML or software strings and / or it may need to be delivered to websites or content management systems (CMSs). We can work with all of these scenarios as we use the latest industry tools including computer assisted translation (CAT), translation memory (TM), desktop publishing (DTP) tools as well as one of the leading website translation management systems.
The process strategy we will use will depend on your unique situation, but in general, we have an experienced, knowledgeable team consisting of project managers, human translators, pre- and post-desktop publishing specialists, engineers, quality assurance testers, and quality check specialists. We will use the right combination of people, processes and tools for your project.
Quality-centered Methodology and Certifications
In addition to our professional team and industry tools, our quality-centered methodology consistently achieves accurate results. It’s very important to have traceable and repeatable processes in order to deliver the highest-quality translations possible, as evidenced by the fact that we work with some of the world’s largest medical companies and medical-device manufacturers. In addition to the ISO 9001 standard, we have the following process certifications:
- ISO 17100:2015 – a quality ISO European standard for translation service providers. It outlines resources and processes to follow in order to achieve high-quality translations.
- ISO 13485:2003 – an ISO standard that outlines specific quality management system requirements for companies that provide medical devices and related services.
Are you involved in the translation and testing process of medical devices? If so, make sure to watch the replay of the webinar and learn more about how we measure quality and how we helped Biosense Webster. We’re here to answer any questions you may have and I invite to contact our nearest office.