How to Choose the Right IFU Translation Company for EU MDR and IVDR
An IFU translation project does not start and end with a translated document. It affects how safely users operate a device, how consistently product information appears across markets, and how smoothly a regulatory team can prepare for launch. Under EU MDR and IVDR, manufacturers must provide IFUs and other device information in the language or languages required by each Member State where they sell the device. The scope can include labels, packaging, manuals, technical documentation, clinical evaluation reports, and post-market documents. For many manufacturers, the question is not simply, “Who can translate this?” It is, “Who can take ownership of this documentation without slowing down our launch?” They need a translation partner they can work with over time, one that retains approved terminology, understands their documentation, and can support revisions as products and market requirements change. What a Good IFU Translation Partner Should Offer A suitable IFU translation company s...