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.
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.