Clinical Trial Documents
Informed consent forms, clinical study reports, protocols, investigator brochures, patient diaries, and lab reports translated with clinical accuracy and regulatory terminology.
Medical Translation Services for Regulated Content
Medical translation is not a job for generalists. Every clinical trial protocol, device IFU, and consent form goes to a linguist with medical or scientific training, then through a three-stage QA review.
Medical Translation Services with Clinical and Regulatory Expertise
Medical translation is the written side of our work, and it covers the full document lifecycle of a treatment or device. Clinical trial teams send us protocols, informed consent forms, clinical study reports, investigator brochures, case report forms, and patient diaries. Regulatory and labeling work covers Summary of Product Characteristics (SmPC), package inserts, patient information leaflets, and the Instructions for Use bundled with each medical device technical file.
We handle regulatory submissions daily: FDA filings (IND, NDA, ANDA, 510(k), De Novo, PMA), EMA centralized and decentralized procedures, MHRA filings, and dossiers for Health Canada, the TGA, PMDA, and ANVISA. EU MDR Regulation 2017/745 requires Instructions for Use in every official language of each market where a device is sold, so we deliver across all 24 EU official languages plus Norwegian, Icelandic, and Swiss German for EFTA/EEA distribution.
Patient records, discharge summaries, and intake forms that need sworn translation services are produced to ICH-GCP standards, with manufacturing content aligned to GMP. Every project is reviewed by a second medical specialist and QA-checked against ISO 17100 and ISO 13485 requirements.
Documents We Translate for Life Sciences Teams
Medical Device Documentation
Instructions for Use (IFU), technical files, software interfaces, packaging, and labeling. EU MDR Regulation 2017/745 requires IFUs in all official EU languages of the markets where the device is sold.
Pharmaceutical Documentation
Summary of Product Characteristics (SmPC), package inserts, patient information leaflets, and labeling for regulatory authority submissions to EMA, FDA, MHRA, and national bodies.
Medical Records and Research
Patient records, discharge summaries, medical journals, research papers, and white papers for hospitals, academic institutions, and research organizations worldwide.
Healthcare Provider Materials
Patient information leaflets, appointment letters, consent forms, and clinical communications for healthcare provider translation at clinics, hospitals, and private practices serving multilingual patient populations.
Telephone Interpreting for Healthcare
Real-time telephone interpreting for scheduled appointments and urgent patient communication, where in-person interpretation is unavailable. Professional medical interpreters ensure accuracy and confidentiality for providers and patients alike.
Sectors We Serve
- Pharmaceutical
- Medical Devices
- Clinical Research and CROs
- Hospitals and Clinics
- Health Insurance
- Academic and Life Sciences Research
- Regulatory Affairs
What Our Clients Say
“I recently used a translation agency in France to translate several administrative and commercial documents into Spanish. The service I received was absolutely exceptional. Not only were the translations accurate and professional, but the team was also very responsive and understanding of my specific needs. BeTranslated truly took the time to understand my context, and the translations perfectly reflected this understanding. I highly recommend their services to anyone needing high-quality translations, and I will not hesitate to use them again in the future.”
paula E.
Google review (FR) , 2 years ago
“Great communication, perfect translations in different languages in a very short notice. I would recommend! We are very pleased, thank you :-)”
Melissa L.
Google review (INTL) , a year ago
“We contacted Betranslated services in July 2024. My daughter had time sensitive documents that required certified translation from Spanish to English. The company accommodated her request and promptly, accurately translated all of her documents ahead of time. The documents showed clearly which part had been translated to make it easy to identify. They were friendly & professional, and we would recommend their services to anyone.”
Lyne G.
Google review (SL) , a year ago
Why Buyers Trust Us
Accreditation and Compliance
ISO 17100-Aligned
Translation services standard
ISO 13485-Aligned QA
Medical-device quality management
EU MDR 2017/745 Compliant
All 24 EU official languages
FDA Submission Experience
IND, NDA, ANDA, 510(k), PMA
HIPAA-Aware Handling
Patient-identifier protocols
CRO and Pharma Vetted
Trusted by clinical research orgs
Medical Translation: Common Questions
Yes. All BeTranslated medical translators hold academic or professional backgrounds in medicine, pharmacy, life sciences, or a related health discipline. Language skills alone are not sufficient for medical translation: subject-matter expertise is a baseline requirement, not a differentiator. We also apply strict confidentiality protocols and NDAs on every project and never use third-party machine translation tools for medical content. We match each project to a translator with documented expertise in the relevant clinical area.
Yes. EU MDR 2017/745 requires that instructions for use and labeling be made available in the official language or languages of the EU member states where the device is placed on the market. Non-compliance can result in the device being withdrawn from the market. We provide compliant translations for all 24 EU official languages.
Every medical translation goes through three stages: primary translation by a qualified specialist, independent review by a second medical translator, and a final terminology and consistency check. For submission-critical documents, a back-translation review is available on request.
Yes. For official filings and submissions we provide certified translation accompanied by a signed statement of accuracy, with back-translation review available on request for submission-critical documents such as informed consent forms and clinical study reports. The certification format is matched to the requirements of the receiving authority, whether that is the FDA, EMA, a national competent authority, or an ethics committee.
All translators and project managers sign full NDAs covering all project materials. We apply strict data handling protocols aligned with HIPAA and GDPR requirements. Patient identifiers are handled according to your organization's de-identification requirements. We do not use third-party machine translation tools for medical content.
We cover 100+ languages for medical content including all official EU languages, Arabic, Chinese (Simplified and Traditional), Japanese, Korean, Hindi, Turkish, Ukrainian, and many more. Our language list covers all markets required for IFU compliance under EU MDR and major global regulatory filings.
5.0/5.0 from 168 Google Reviews
Professional Medical Translation, Delivered on Time.
Get a free assessment of your medical translation project. We confirm specialist availability, QA requirements, and a clear timeline as quickly as possible.
Medical Linguists
Three-Stage QA
100+ Languages