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Practical articles on translation quality, AI in regulated content, terminology and market entry, written by the linguists and project leads who do the work.
The language is the same, and the geographic market is the same, but there are different cultural contexts and emotional triggers involved. This wasn’t a translation problem.
A coronary stent manufacturer updating French documentation for MDR 2017/745 ends up with three documents that all need to speak the same terminological language – even though the register the original IFU was translated in no longer matches what MDR requires.
A retrievable vena cava filter IFU carries component names that appear in both the procedural text and the bilingual product drawing labels – and a mismatch between the two is exactly where a labeling reviewer will look.
A PTA dilatation catheter IFU spans dozens of procedural steps and product variants – all of which need to land in French with the same precision as the source, inside a multilingual document where any structural inconsistency is immediately visible.