A High-Risk Device. A Fixed European Timeline.
For a Class III medical device, the IFU is not ancillary marketing content. It carries technical and safety information that intended users rely on to understand appropriate device use, warnings, precautions, contraindications, and procedures.
The client, a U.S.-based MedTech manufacturer specializing in implantable cardiac devices, was preparing a new device for European market entry. Its English IFU needed to become a coordinated 24-language document set supporting planned markets and applicable MDR and national language requirements.
The assignment was therefore much larger than translating one document 24 times. Sesen had to help the client create a controlled multilingual content system in which technical meaning, safety language, terminology, document structure, and final presentation stayed aligned through a time-sensitive regulatory program.
Safety-critical meaning
Warnings, precautions, contraindications, procedural instructions, and device-handling information had to remain precise across every target language. Small wording differences could create unnecessary review questions or change how technical information was understood.
Fragmented terminology
The content environment included legacy IFUs, related product families, prior translations, internal terminology, and work completed by multiple language vendors. The new multilingual set needed a controlled vocabulary rather than 24 independent translation decisions.
Translation and layout under one deadline
The regulatory schedule left little room for late-stage correction. Translation, bilingual review, multilingual DTP, and final-context validation had to operate as one coordinated production system instead of a series of handoffs.
