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Medical translation services

SimulTrans translates medical documents, clinical research, and other life science content into 100+ languages.
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Certified translations by medical subject-matter experts

Clinical research, technical manuals, instructions for use, regulatory documentation, and medical software applications contain highly technical terminology and must follow ethical and legal regulations.

SimulTrans’ subject-matter experts leverage a defined process to accurately translate life science content for use by patients and clinicians.

All of our translations are backed by an ISO-certified quality management system, which enables us to meet the rigorous standards of the medical industry. When requested, translations can be back-translated to verify they are 100% accurate.

Our medical localization services include:

  • Medical document translation
  • Clinical trial translation
  • Regulatory compliance translation
  • Diagnostic software localization
  • Medical device manual translation
  • Instructions for use translation
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Our end-to-end services include performing independent linguistic reviews and providing certificates of translation.
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SimulTrans’ translators are medical subject-matter experts and full-time professionals with a minimum of 5 years of experience,  who have worked on hundreds of life science projects.
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Our engineers ensure your software will work in your target countries, and our publishers deliver manuals and instructions that meet regulatory guidelines.
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How it works

  • 1.To begin the translation process, upload your files, receive a free quote, and approve it.
    Pro tip: for ongoing translation needs, connectors to your file repository make the content transfer process even easier.
  • 2.SimulTrans’ expert linguists translate your content into your requested languages on your schedule.
  • 3.SimulTrans’ reviewers check all content for terminology accuracy and linguistic style.
  • 4.SimulTrans formats your content in its original source format.
  • 5.If requested, SimulTrans conducts back translation to ensure accuracy and provides signed certificates of translation.
  • 6.You receive your translated content.
  • 7.When you need updates or have more content to translate, SimulTrans uses translation memory to ensure you don’t pay to translate the same text twice.

Your long-term medical localization partner

SimulTrans is the preferred translation partner of so many leading life science companies because of our deep understanding of the industry’s unique needs, including global regulatory processes. 

Our experienced project managers are always ready to jump on a call and find the best solution for your needs. This flexible, hands-on attitude is why we’ve been able to achieve a 97% customer satisfaction rate in 2025 and remain a leader in the industry since 1984.

Medtronic Signant Health GE Healthcare

Benefits of partnering with SimulTrans:

  • There’s never an added cost to you for the tools and technology we use to translate your materials.
  • We’ll always suggest the most cost-effective solution for your needs.
  • Translation memory saves time and money by reducing unnecessary rework while maintaining consistency.
  • The SimulTracker portal keeps every project organized and improves collaboration between teams.
  • We connect our systems to yours to automate ongoing translation projects, accelerating work and reducing admin needs.
Featured eBook
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Featured eBook

13 Best Practices for Successful Medical Translation

Get a free excerpt from the eBook and learn how to produce clear and accurate translated content to safely inform patients, practitioners, and others.
Download

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Frequently asked questions

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.

What qualifications do SimulTrans' translators have?

 

SimulTrans works only with professional linguists who are native speakers of the target language and have at least five years of specialized experience. Many of our translators hold degrees in medicine or clinical research and are fluent in industry-specific terminology.

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.

How long does medical translation take?

Medical translation projects can take between three days and three months, depending on word count and team size. Each translator usually translates about 2,000 words per day, and our translators work simultaneously so the number of target languages won’t impact your timeline.

We can accommodate almost any timeline by scaling your translation team. A typical team has three translators and two reviewers per language, while some projects have over 100 translators per language!

What is back translation, and how is it used?

"Back translation” involves translating text back into the source language, and may be required as an additional quality assurance step for some projects (some review boards and ethics committees advocate using two separate back translations).

Back translations are completed independently by linguists who were not involved in the initial translation and do not have access to the original source material. Therefore, a back translation will never be 100% identical to the source text. Rather, it helps to identify missing words, mistranslations, or ambiguities that occur due to language nuances.

What file formats do you accept? 

SimulTrans works with any file format, including Excel, Word, JSON, HTML, XML, DITA, InDesign, FIGMA, etc.

Our team manages the translation, back translation, and multilingual formatting of any medical,  regulatory document, or technical file you need. From 510 (k) submissions, Premarket Approval (PMA) documents, Device Master Records (DMR), Design History Files (DHF), Risk Management Files (ISO 14971), Instructions for Use (IFU), to labeling under 21 CFR 801. We also provide translation certificates.

Does SimulTrans specialize in EU MDR translation?

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.

Does SimulTrans provide IVDR-compliant translations?

Yes. SimulTrans is an ISO-certified provider of medical translation. We deliver all types of translations (and back translations) for in vitro diagnostic medical devices (IVDs) using qualified linguists.

Our certified translations help companies meet EU MDR, IVDR, and FDA requirements and support the safety, quality, and regulatory compliance of their medical devices.

Is SimulTrans an ISO-certified translation provider?

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.

Does SimulTrans specialize in FDA‑compliant translations?

Yes. SimulTrans is certified to three ISO standards and follows a rigorous quality management system. Our ISO‑driven processes and certified translations help medical companies meet regulatory requirements such as FDA 21 CFR Part 801 for medical device labeling, including the rule that any foreign‑language content on a label must be accompanied by a complete English translation, and vice versa.

Who are SimulTrans' typical clients? 

SimulTrans serves a wide range of organizations, such as Medical Device Manufacturers, Pharmaceutical and Biotech Companies, Contract Research Organizations (CROs), and In Vitro Diagnostic (IVD) Manufacturers.

Our clients share a common need: accurate, traceable, and regulatory-compliant translations that can withstand the scrutiny of international health authorities.

Do you provide a translation solution that complies with Section 1557 of the ACA?

Yes, SimulTrans provides translated documents that help people fully understand their rights and access healthcare services, supporting compliance with Section 1557 of the Affordable Care Act (ACA). This means  clear, accurate translated documents,  reviewed by human linguists to meet the high standards required by law. 

Do you provide SaMD and SiMD localization services?

SimulTrans provides medical software localization for both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Services include terminology extraction, user interface translation, UI and controls adjustment, reformatting, and thorough testing using automated LQA processes combined with human testers.

We’re ready for your next translation or localization project.

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