ISO Certified Translation Services
A requirement of the MDR/IVDR (EU) 2017/745 & 746 is to provide documentation for medical devices in local languages. This includes IFUs, elements of product labelling, and Declarations of Conformity, for example.
Our Translation arm is a leading provider of translation services in Northern Europe and is ISO 13485:2016 certified as such.
Human Translation
All our translations are done and edited by human beings. The term human translation is used as opposed to machine translation. Human translation is executed by a human translator, whereas machine translation is executed by a translation machine and edited by a post-editor.
We only use native-speaking linguists with specialist knowledge and expertise in the MedTech arena.
Upon request, we can provide Certificates of Accuracy according to ISO 17100:2015 requirements, and our work also carries full indemnity insurance against any material losses.