Case Study – Translations for medical devices in compliance with the EU MDR regulation

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Multilingual translation of medical device documentation

Translating technical documentation for a medical device intended for the European market means working in an environment where linguistic accuracy, scientific expertise and regulatory compliance are closely interconnected. Language proficiency alone is not enough: terminology and content must be managed in line with the requirements of the EU Medical Device Regulation (MDR) 2017/745.

In this case study, we explain how Aglatech14 organised a technical documentation translation project covering 22 European Union languages, involving specialised professionals and ensuring terminological consistency, quality and close attention to regulatory requirements across every language version.

A project that demonstrates how a structured workflow and specialist expertise are essential when managing multilingual communication in the medical sector.

Download the full case study using the button below and discover in detail how we managed the project.