Medical translation services

What is translation certification?

Many pharmaceutical, medical device, and contract research organization clients need certificates of translation to comply with specific process requirements (or simply for extra peace of mind).

SimulTrans provides signed certificates (in electronic format) that verify translations are true, accurate, complete, correct, and performed to the best of the translators’ ability and expertise.

How much does medical translation cost?

Costs vary by language, typically corresponding to the cost of living in the target countries (for example, translation into Simplified Chinese is about a third of the cost of translation into Swedish). SimulTrans provides discounts based on repeated text by leveraging translation memory. Document formatting costs are typically calculated on a per-page basis.

Use this cost calculator to get an estimate based on an average language cost.

What is back translation and when is it required for medical and clinical documents? 

Back translation is the process of translating a previously translated document back into the original source language, independently and without reference to the source text. It serves as a critical quality assurance step in medical, clinical, and regulatory translation workflows.

Back translations are required or strongly recommended in several contexts:

• Clinical trials: institutional review boards (IRBs) and ethics committees frequently require back translation of informed consent forms, patient questionnaires, and study protocols to verify accuracy
• Regulatory submissions: certain health authorities require back translation as evidence of translation fidelity for labeling and IFU documentation
• Instrument validation: back translation is a standard step in adapting clinical outcome assessments (COAs), patient-reported outcomes (PROs), and psychometric instruments for new language markets

At SimulTrans, back translations are always completed by linguists who had no involvement in the original translation and no access to the source material. Because language nuance and structure differ across languages, a back translation will never be word-for-word identical to the original, and that is by design. Meaningful divergences are flagged, reviewed, and resolved, helping to identify missing content, mistranslations, or ambiguities before submission.

Can you translate medical device documents for EU MDR compliance?

Yes. SimulTrans specializes in medical device translation and helps companies to be fully compliant with EU MDR 2017/745.

We accurately translate all manufacturer information that must accompany your device, including documents, labeling, and Instructions for Use (IFUs) into over 100 languages. We offer forward and back translations and certificates of translation.

Which ISO certifications does SimulTrans hold for translation and post-editing? 

Yes. SimulTrans has three separate certifications.

• ISO 9001 certification. It ensures we have a well-documented process, follow it consistently, and strive to continuously improve.

• ISO 17100 certification. It aims to standardize terminology, define basic requirements for services, and create a framework for interaction between customers and service providers.

• ISO 18587 certification. It details requirements for human post-editing of machine translation.

Which life sciences organizations do you serve? 

SimulTrans serves organizations across the life sciences sector where translation accuracy, traceability, and regulatory compliance are non-negotiable:

• Medical device manufacturers requiring IFU, labeling, and technical documentation translation for global market entry
• Pharmaceutical and biotech companies needing clinical trial documentation, patient-facing materials, and drug labeling in multiple languages
• Contract research organizations (CROs) managing multilingual regulatory submissions and study documentation across jurisdictions
• In vitro diagnostic (IVD) manufacturers meeting EU IVDR and FDA requirements for diagnostic device documentation

What our clients share is a common standard: translations that are accurate, traceable, and built to withstand scrutiny from international health authorities, including the FDA, EMA, and notified bodies.

Do you localize Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)? 

Yes. SimulTrans localizes both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) for global regulatory submissions and market entry.

Our medical software localization services cover the full workflow,  terminology extraction, user interface translation, UI and controls adaptation, reformatting, and rigorous testing, combining automated language quality assessment (LQA) with human testers, ensuring your software meets the accuracy and usability standards required by FDA, EU MDR, and IVDR.