How verified French device-component terminology and source-PDF structural validation produced a consistent French IFU across a balloon catheter range with multiple reference numbers and diameter variants.
The client
An international manufacturer of peripheral vascular intervention devices, producing a range of PTA balloon dilatation catheters available in multiple reference numbers and diameter variants. The Instructions for Use (IFU) serve as the procedural reference for interventional radiologists and vascular surgeons working in catheterization laboratories, covering indications, contraindications, device preparation, and technique steps across the full product suite.
The challenge
The translation of an IFU for a PTA requires linguistic accuracy for the full product family across multiple reference numbers and diameter variants, each with its own specifications, procedural steps, and caution statements. In French, those steps need to land with the same procedural clarity as the source, because the reader is an interventional radiologist or vascular surgeon making technique decisions in real time.
For this project, the French format added a specific structural constraint. The IFU was formatted as a multilingual PDF with the French column sitting immediately beside German, Spanish, and Turkish equivalents. Any deviation from the document’s structural conventions – inconsistent device-component terms, format drift, or untranslated content in the wrong column – is visible when performing a side-by-side review.
There was also a strict element of regulatory adherence to consider. Any text appearing physically printed on the device itself had to remain in English per manufacturer specification. In a multilingual IFU where translation columns run side by side, correctly applying that boundary required visual verification against the source document, not just a terminology check.
The solution
The source PDF IFU served as a structural reference at every stage – confirming that the French column followed the document’s layout conventions, that device-on-label content remained in English per manufacturer specification, and that unit conventions switched from imperial-first to metric-first measurement order throughout.
Additionally, French device-component terms were applied from a product-specific glossary – port latéral for lateral arm, capteur de pression for pressure transducer – replacing literal or anatomically imprecise alternatives that had appeared in earlier translation passes.
The results
- Complete French IFU delivered across the full product suite
- Adherence to a 4-language document structure, enabling efficient review and approval
- Product names, unit conventions, and catalog references aligned to the manufacturer’s approved French-language specifications.
- Verified French device-component terminology applied throughout – port latéral, capteur de pression – corrected against the product-specific glossary.
- Device-on-label content correctly excluded from the French column, confirmed by source PDF structural verification before delivery.
