Clinical documentation, regulatory submissions, medical device files, patient information, and pharmaceutical dossiers.
Medical and pharmaceutical translation is the domain where precision is not a quality attribute â it is the baseline requirement. A patient information leaflet that contains a mistranslated dosage instruction, a clinical trial protocol with imprecise eligibility criteria in the target language, a regulatory submission with inconsistent terminology: these are not quality problems. They are safety and compliance failures.
All medical and pharmaceutical translation at SenseTranslations follows an ISO 17100-compliant workflow: primary translation by a medically qualified specialist, independent review by a second qualified specialist, and QA check before delivery. The translators we use hold degrees in medicine, pharmacy, nursing, life sciences, or medical engineering, with additional language qualifications.
Clinical trial documentation requires particular care for regulatory integrity. We maintain version control and audit trails for all clinical translation projects. Delivery is accompanied by a quality declaration. We have supported AIFA and EMA submission workflows and produce terminology consistent with the relevant authorityâs own published guidelines.
For medical device manufacturers, we translate CE marking technical documentation, MDR/IVDR compliance files, instructions for use (IFU), and device labelling. Device labelling is particularly demanding: it must be accurate, unambiguous, and within the space constraints of the physical label.