Responsive Translation recently achieved ISO 13485:2016 certification. Our approach to quality management helps us provide the highest quality translation to medical device companies worldwide.

Quality translation is life-and-death important to medical device users. Translation allows more people to enjoy the benefits of different medical devices, but user safety is on the line with every translated word. So how do you ensure that users won’t be led astray by a substandard, and potentially dangerous, translation?

Quality Certification

So, medical device translation is highly regulated. Medical device companies may be required to work with an ISO 13485 certified company in order to bring their medical devices to market. But even when regulatory authorities don’t require it, ISO 13485 certified companies have demonstrated that they’re up to the challenge of providing quality services, including translation.

Responsive Translation has recently achieved ISO 13485:2016 certification, in addition to our ISO 9001 certification, which we’ve held for many years. Long-time readers may also recall that we previously held ISO 13485 until 2017, but we’ve become ISO 13485 certified again at the request of our medical device clients. We were happy to do so and have our approach to quality validated again.

Experienced Linguists

It’s not all about the company though. When you get right down to it, a translation can only be as good as the translation team that created it. Translating medical device documentation requires experienced linguists and subject matter experts with extensive linguistic and medical knowledge to convey the right meaning. That’s why Responsive Translation has honed its translation teams over many years, recruiting the most qualified linguists and providing them with the resources and tools they need to be successful.

Multiple Eyes and Quality Control

Medical device translation, like other types of specialized translation, deserves a customized process with multiple quality control steps, including different validation and review options. I cannot overstate the importance of having multiple eyes come together to refine a translation and ensure its accuracy and effectiveness. That’s why Responsive Translation has helped many medical device companies by customizing our QA workflows to meet or exceed their regulatory and market requirements.

Quality Medical Device Translation

Certified for ISO 9001 and now ISO 13485 again, Responsive Translation has been providing foreign-language translation to high-compliance industries for more than 30 years.

For more information about our range of services and how we can help you, please get in touch at 646-847-3309 or [email protected].