Global Translation Requirements for Medical Devices

Companies exporting their devices to international markets often underestimate the importance of translations. You may have an excellent product and a top distributor, but if your translations of device labels and IFU are poor, it can hurt sales and damage the reputation of your company. And, poor translations pose a liability risk if a misunderstanding leads to misuse of your device by a patient or user.

In this article, we'll answer your biggest questions about requirements and best practices for translating device labeling and Instructions for Use (IFU). You will learn:

• What do European regulations and others say about translations?
• Is it possible to be exempt from translation requirements?
• What are the risks of not translating our materials?
• When to go above and beyond the minimum translation requirements?
• What should we consider when hiring a translation company?

You will learn all this and more in this 8-page white paper.