Medical and Clinical Translation for Regulated Healthcare Content.
Medical translation sits at the intersection of clinical accuracy and regulatory compliance. A Summary of Product Characteristics translated for a German BfArM submission needs to meet specific structural and terminology requirements from approved sources. A clinical evaluation report prepared under EU MDR 2017/745 must reflect the regulatory framework in language, structure and terminology. These are not general writing tasks with specialist vocabulary -- they are regulated documents where translators who do not understand the regulatory context produce filings that require substantial rework.
Our medical translators have clinical or biomedical backgrounds in addition to their language qualifications. For medical device documentation under EU MDR and EU IVDR, we work with the relevant European standards and terminology guidance. For pharmaceutical content, we use EMA and national medicines authority approved terminology as the reference for each target language.
We maintain a project-specific bilingual medical glossary for each client, covering product names, generic terms, mechanism of action phrasing, and regulatory-specific terminology. This glossary is updated at the start of each engagement and applied consistently across all documents in the project.
What this includes
- Summary of Product Characteristics (SmPC)
- Instructions for Use (IFU)
- Clinical Evaluation Reports (CER)
- Risk Management Files (EU MDR / ISO 14971)
- Patient information leaflets
- Clinical study protocols and reports
- Labelling and packaging content
- Device history records
Medical device CE marking, pharmaceutical regulatory submissions, clinical trial support, patient documentation, BfArM and EMA filings.