High-Quality Medical Device Translation

When selling and distributing medical devices internationally, there is no greater ally than high-quality medical device translation.

Medical device manufacturers are increasingly going global to reach key consumers in the multibillion-dollar medical device market. But doing so demands meticulous compliance within a constantly evolving regulatory framework where high-quality medical device translation and localization is more often than not required. And even when it’s not required, liability concerns make it more than worthwhile.

Regulatory Compliance and Liability Reduction

For health and safety reasons, users and caregivers need to know how to properly use and maintain their medical devices. However, users and caregivers can’t benefit from brochures, label packaging, instructions for use and other appropriate documentation if they don’t understand what they are reading. High-quality medical device translation and localization into the local language affords users and caregivers the opportunity to employ medical devices in the ways they were intended. This helps reduce adverse events as well as liability in the event of a claim or lawsuit.

As you know, in major medical device markets, regulatory authorities won’t permit medical devices to be sold within their territories if key medical device information for consumers is not translated into the local or national language. Regulatory authorities have a duty to protect those who live within their territories and want to see evidence of high-quality medical device translation.

The good news is that medical device manufacturers can manage risks more efficiently and achieve regulatory compliance today with the help of Responsive Translation’s translation expertise.

Expert Medical Device Services

For more than 20 years, Responsive Translation has been providing error-free translation, localization, validation and review services designed to meet diverse international regulations, reduce adverse events and prevent liability claims. We are ISO 9001 and ISO 13485 certified and specialize in translation quality for compliance-intensive clients.

Every day Responsive Translation brings customized workflows, advanced terminology management and rigorous quality assurance processes to every medical device project, ensuring that we meet or exceed all quality, budget and timeline requirements for each client.

While we take pride in the specialized skills and knowledge of our network of medical device translators, subject matter experts and reviewers, our policy is still to triple check everything. We know that lives depend on high-quality medical device translation and it is our duty to provide it.

Next Steps

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

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