Translation & Technical Documentation for medical devices

In medical technology, translation is not a language service but part of conformity. The MDR requires instructions for use and labelling in the language each member state specifies for its territory; the IVDR sets out the same for in-vitro diagnostics. Anyone placing products on the market across Europe may need documentation in up to twenty-four official languages — and must be able to show how it was produced.

For buyers, the process matters more than the price per line. Does the provider work to ISO 17100, with a specialist translator and a separate reviser? Do they maintain a translation memory and a terminology database, so the same clamp is named identically in every language and every revision? And is the workflow documented well enough to survive an audit — because in case of doubt it is a notified body reading along, not the end customer.

The providers listed here cover different parts of the chain: specialist translation, authoring technical documentation from scratch, terminology work, typesetting multilingual package inserts, and maintenance across the product lifecycle. Anyone preparing a submission should settle early which of these steps stay in house — harmonising translations after the fact costs more than running them from one source from the start.