The medical device industry is shaped by rapid innovation, evolving regulatory demands, and the need for precise multilingual documentation. Every instruction, label, or software interface must comply with EU MDR/IVDR, FDA regulations, and global safety standards. Our Medical Device Translation Practice delivers high-accuracy, regulatory-ready translations for Class I, II, and III devices—ensuring safety, usability, and compliance across global markets.
Translators with backgrounds in biomedical engineering, device technology & clinical operations.
Deep familiarity with EU MDR 2017/745, IVDR 2017/746 and FDA 510(k)/PMA requirements.
Full support for 510(k), PMA, STED dossiers, CE marking and global regulatory filings.
End-to-end localization for SaMD, embedded UI, touchscreens, mobile apps & web portals.
Robust workflows aligned with ISO 13485 & ISO 17100, plus terminology governance.
Specialized DTP & artwork teams ensure multilingual layout integrity and UDI compliance.
We support device manufacturers, notified bodies, regulatory consultants, and global distributors through each stage of the device lifecycle.
Accurate, audit-ready translations are critical for global device approval.
We translate:
Our advantages:
Clear, accurate instructions are essential for device safety.
We translate and localize:
Benefits:
Today’s medical devices rely heavily on software. We ensure linguistic and functional accuracy across user interfaces.
We localize:
Our technical strengths:
Our translators understand the engineering, clinical validation, and operation workflows of modern devices.
We follow regulatory restrictions for promotional material in each region.