DFU and IFU Translations

The most important medical device markets in the world are Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Japan, Mexico, Spain, South Korea, Turkey, the United Kingdom and the United States. In most of those markets, accurate and compliant DFU and IFU translations are required when selling medical devices across borders.

Why Translate DFUs and IFUs?

Every day medical devices improve the quality of care and the quality of life for people located around the globe. Medical devices include appliances, instruments, software and other articles that can be used to prevent, diagnose, monitor and treat diseases. Accurate translation is essential to the proper use of these devices.

Directions for use (DFUs) and instructions for use (IFUs) help patients and caregivers to use medical devices in the way they were intended, if they understand the instructions.

To meet the needs of medical device patients in other countries, DFUs and IFUs need to be translated into the national language. In fact, all major medical device markets require this. Directions for use and instructions for use are typically included in labeling requirements mandated by regulatory authorities such as the Food and Drug Administration in the United States, Pharmaceuticals and Medical Devices Agency in Japan and medical device regulatory bodies in the European Union and around the world.

The risks of not translating DFUs and IFUs include denial of regulatory approval, liability lawsuits, product seizures, fines and even imprisonment. High-quality translation is needed so that patients can correctly use and maintain their devices, and manufacturers can reduce adverse events and limit liability.

Medical Device Services

Responsive Translation specializes in high-quality medical device translation. We are ISO 9001 and ISO 13485 certified and have been serving compliance-intensive companies and manufacturers for more than 20 years.

We believe in quality and customer satisfaction. For every project, we provide customized workflows, rigorous quality assurance, experienced expert medical translators and subject matter experts, and advanced terminology and translation memory management. In 2016, we received a 93.55% NPS score as audited by BSI, ranking first for customer service among language service providers globally.

We check too. Some medical device manufacturers prefer to have their distributors approve or do the translation themselves. However, using those translations unchecked is not in a manufacturer’s best interest. Review and validation by an experienced language service provider familiar with medical devices, like Responsive Translation, adds a much-needed layer of quality assurance and helps to keep everyone in the market and back at HQ on the same page, regardless of language.

Next Steps

To discuss your DFU and IFU requirements, or to receive more information about Responsive Translation’s suite of medical device translation, review and validation services, please contact us at +1-212-355-4455 or services@resptrans.com.

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