A mistranslated IFU or a regulatory submission with terminology inconsistencies can delay market authorisation by months. We translate medical content with the clinical accuracy it requires.
What is included
Life sciences specialist assigned
Regulatory context review
Medical terminology reference
Human translation with second-linguist review
Consistency check against related documents
Two revision rounds
7 business days for standard medical translation projects.
What we translate
Instructions for use (IFUs), clinical study reports, investigator brochures, informed consent forms, labelling, technical files, and regulatory submissions for medical device and pharmaceutical clients. We also handle EU MDR and IVDR technical documentation, European Pharmacopoeia content, and clinical trial protocols.
Our medical translators have backgrounds in medicine, pharmacy, biomedical engineering, and clinical research. They have worked in clinical settings or pharmaceutical companies before entering translation. They read a clinical study report as a clinician, not as a translator who has studied medicine.
EU MDR and regulatory compliance
We work with medical device manufacturers preparing technical documentation under EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). We understand the documentation structure required, the terminology standards that apply, and the consistency requirements across a technical file. Our translations have passed notified body review without RFIs on first submission multiple times.
FAQ for this service
Our medical translators hold relevant academic qualifications in medicine, pharmacy, or biomedical fields, and have professional experience in clinical or pharmaceutical settings. We do not require a single specific certification but evaluate background, experience, and test translations for each domain.
Our translation process meets the core requirements of ISO 17100 including two-translator workflow, source text verification, and project management. If a client requires a formal ISO 17100 compliance statement, contact us to discuss.
