Medical and pharmaceutical translation covers medical device instructions for use, clinical trial documents, marketing authorisation dossiers, patient information leaflets and hospital correspondence. mots Tercüme provides this service to pharmaceutical and medical device companies, hospitals and research institutions.
Scope of the service
Translation, a terminology list, a separate check of doses and units and delivery within a confidentiality regime are within this service. Subject-matter expert review, if requested, is added as a separate layer.
Special category data
Documents carrying patient information are special category personal data under the KVKK (Turkish Personal Data Protection Law, No. 6698). These documents are processed with restricted access and are not uploaded to any free-of-charge translation tool or language model service.
Dose and unit check
Dose, unit, frequency of administration and route of administration are compared with the source separately after translation. A slip in these values can go unnoticed inside a fluent text.
Abbreviations
Medical abbreviations can carry different meanings depending on the specialty and the institution. An abbreviation whose meaning is not certain is not expanded by guesswork; it is sent to the organisation as a query.
Language suited to the reader
Information aimed at a physician and a patient information leaflet explain the same subject in different language. In patient-facing text, plain wording is chosen over technical terms.
Medical device documents
Instructions for use, labels and warning texts are prepared in the layout required by the regulations. The severity level of warning statements is preserved in translation.
Clinical trial documents
The informed consent form, the protocol synopsis and the case report form are aimed at different readers. In a consent form, language the participant can understand is what matters most.
Marketing authorisation dossiers
In authorisation and registration dossiers, the same information is repeated across several documents. For the sake of the dossier's consistency, it is tracked separately that a statement updated in one document is updated in the same way in the others.
Terminology consistency
The same active substance, the same device component and the same procedure name are rendered the same way throughout the dossier. In an authorisation dossier, inconsistent terminology prolongs the review process.
What is needed as input
An editable version of the document, the target reader and the organisation's approved terminology list, if any, are sufficient. Previously approved translations are the basis for consistency.
Delivery format
The translation is delivered in line with the source layout and within the confidentiality regime. Files are transferred through the channel specified by the organisation.
Which project types it comes with
This service is most often requested together with medical device documentation translation. The language of the sector is covered on the medical devices and healthcare services pages.
What is not included
Medical opinion, clinical evaluation and regulatory compliance approval are not part of this service. An inconsistency noticed in the source is not corrected; it is reported as a query.
Takeaway
In medical translation two things are managed together: the accuracy of the figures and the confidentiality of the data. When either is missing, the translation cannot be used, however correct its language.