Certified Medical Translation Services for Medical Devices, Pharma & Clinical Research

Medical translation demands more than language fluency. A mistranslation in an IFU, a drug data sheet, or a clinical trial consent form carries direct consequences for patient safety and regulatory compliance — which is why every project at Global LTS is handled by translators who are specialists in your specific medical sector first, and linguists second.

What is medical translation?

Medical translation covers any documentation relating to the medical, pharmaceutical, or life sciences sectors. That includes patient-facing materials such as consent forms and information leaflets, regulatory submissions, clinical trial documentation, device labelling, post-market surveillance reports, and training content for healthcare professionals.

What sets it apart from other specialist translation fields is the consequence of error. A mistranslation in a drug data sheet, a device IFU, or a clinical trial consent form can affect patient safety and create regulatory liability. Generalist translators working from a medical glossary are not sufficient. The work requires people who understand the clinical or regulatory context behind the text — not just the words.

At Global LTS, every medical translation is handled by a translator with direct experience in the relevant branch of medicine or life sciences, reviewed by a second specialist linguist, and delivered under our ISO 17100:2015-certified workflow.

Medical Device Translation for CE Marking, UKCA, and EU MDR

Manufacturers selling medical devices in the EU must provide Instructions for Use (IFUs), labels, safety warnings, and supporting documentation in the official language or languages required by each member state, as mandated by EU MDR (Regulation (EU) 2017/745). For the UK market, UKCA marking requirements apply separately following Brexit.

Non-compliant documentation can delay market entry, trigger regulatory action, or result in device recalls. Accurate, terminology-consistent translations are not a box-ticking exercise, they are a regulatory requirement.

We support medical device manufacturers with:

• IFU translation — Instructions for Use translated into all required EU and global languages, with full terminology consistency across product lines.
• Device labelling translation — Labels, symbols, and warnings translated accurately for multi-market distribution.
• Technical file documentation — Translation of technical files, risk management reports, and clinical evaluation reports for regulatory submissions.
• CE and UKCA marking support — Ensuring documentation meets the language requirements for EU member states and the UK.
• Post-market surveillance materials — Periodic Safety Update Reports (PSURs), post-market clinical follow-up (PMCF) documentation, and vigilance reports.
• Software documentation (SaMD) — Translation of software UI, help files, and accompanying documentation for Software as a Medical Device

Our medical device translation clients include C-Trak (Apollo gamma probe system), GM Instruments (rhinometry devices), and global pharmaceutical companies requiring ongoing multilingual documentation support across 32+ languages.

All translations follow ISO 17100:2015 workflows and are backed by our Lifetime Quality Guarantee.

For device manufacturers who also need manuals, installation guides, and engineering documentation translated, see our technical translation services.

Medical Documents We Translate

ISO 13485 documentation translation

ISO 13485 is the international quality management standard for medical device manufacturers. Maintaining certification requires that your QMS documentation — procedures, work instructions, risk management files, and audit records — is available in the languages required by your regulatory markets and your own workforce. We translate ISO 13485 documentation for manufacturers operating across multiple markets, maintaining terminology consistency between your QMS and your product documentation so the two sets of records align under audit.

 Health and safety documentation

Health and safety documentation must be understood by every employee it applies to, regardless of their first language. For manufacturers, construction companies, and logistics operators with multilingual workforces, that means translating risk assessments, COSHH data sheets, safe operating procedures, and site safety notices into the languages your teams actually speak. We translate health and safety materials into 120+ languages, with translators who understand both the regulatory context and the practical environment the documents will be used in.

How Our Medical Translation Process Works

Step 1 — Project brief You share your documents, target languages, regulatory context (EU MDR, UKCA, FDA, etc.), and deadline.

Step 2 — Translator matching We assign translators with direct experience in your specific medical sector — not just your language pair.

Step 3 — Translation Your translator works with your approved terminology glossary (or we build one) to ensure consistency across all documents and product lines.

Step 4 — Independent review A second specialist translator reviews the output against the source for accuracy, terminology, and regulatory compliance.

Step 5 — Certification & delivery We issue a signed Certificate of Accuracy with every project. All workflows follow ISO 17100:2015.

ISO 17100:2015 Certified Medical Translation

ISO 17100:2015 is the international quality standard for translation services. It sets out specific requirements for the entire translation workflow, covering translator qualifications, the mandatory use of a second independent reviewer, project management procedures, and quality assurance at every stage.

For medical translation, it matters more than in most other fields. A single-translator workflow with no independent review is not sufficient for clinical, regulatory, or pharmaceutical content. ISO 17100 certification means that a documented, auditable process governs every project, and that no translation reaches a client without having been checked against the source by a qualified second specialist.

What ISO 17100 means in practice at Global LTS

Every medical translation we deliver follows a six-stage ISO 17100-certified process:

• Qualified translator assignment. Your project is assigned to a translator with subject-matter expertise in your specific medical or pharmaceutical sector, not a generalist working from a glossary.

• Terminology management. We work from your approved terminology glossary or build one at the outset, ensuring consistency across all documents and product lines.

• Translation. Your specialist translator produces the target-language document with full knowledge of the regulatory and clinical context behind the source text.

• Independent revision. A second qualified specialist reviews the translation against the source for accuracy, terminology consistency, and regulatory compliance.

• Proofreading. A final linguistic quality check is carried out before delivery.

• Certificate of Accuracy. Every completed project is accompanied by a signed Certificate of Accuracy, confirming the translation is complete, accurate, and delivered under an ISO 17100:2015-certified process.

Why ISO 17100 certification matters for regulatory submissions

Regulatory bodies including the MHRA, EMA, and FDA expect medical documentation to meet defined quality standards. When submitting IFUs, clinical evaluation reports, or pharmacovigilance documents in multiple languages, ISO 17100 certification provides an auditable quality framework that supports your regulatory filings and demonstrates due diligence in your translation process.

For manufacturers working toward EU MDR compliance or preparing for multi-market device launches, working with an ISO 17100-certified provider is not just best practice. It is a defensible position if your documentation is ever scrutinised by a notified body or regulatory authority.

The benefits of using Global LTS for certified medical translation services.

In the medical and pharmaceutical sectors, the quality and accuracy of translations are of paramount importance because lives literally can depend on them.

We have over a decade of experience in delivering complex translation projects and have a team in place to handle your medical translations too.

What makes our medical translators the best in the UK and internationally?

Our medical translators meet the following criteria:

• Minimum of 5 years as professional translators
• Experience within the medical translations sector
• Experience within the specific branch of the medical industry matching your sector

Knowledge and expertise

We’re aware that a medical translator needs to have a wealth of knowledge about medicine varying from biochemistry, physics, mathematics, pharmacology and more, to truly offer an excellent standard of medical translations.

Vast medical translations experience

Our medical translators are chosen for their experience, aptitude and qualifications.

They provide medical translation services on daily basis.

Their knowledge and experience help them understand healthcare professionals and healthcare providers, so they can provide an accurate translation that uses the correct and up-to-date terminology.

Medical specialisation

For each project, we source professionals with prior knowledge in the area of expertise required for the job at hand. We will match translators with your particular medical sector, whether you need to translate patient information research papers or medical records, or pharmaceutical production instructions, we have the team for you.

A vast network of professional medical translators

When you work with Global LTS, you are tapping into our network of thousands of tried and trusted professional medical translators.

All of our expert translators working on medical translations have at least five years of experience working as translation specialists within the medical industry.

And the ones we choose for medical projects will have the appropriate training, qualifications and experience to understand medical terminology and have a full appreciation of the issues involved.

Certified Medical Translation Services

We offer certified medical translations. We ensure that all translations adhere to the highest standards of accuracy and precision by using only experienced translators specialized in the particular branch of medicine reflecting your sector’s needs.

We follow the rules and guidelines related to certified translation and can issue a signed Certificate of Accuracy.

ISO 17100:2015 certified

All our medical translation processes are certified to the standard ISO 17100:2015 certified.

Summary

Global LTS provides certified medical translation services for both professional and patient-facing materials, from highly technical pharmaceutical documentation and medical device IFUs through to patient information leaflets, clinical trial consent forms, and training manuals.

For professional-facing materials, our translators apply exact specialist terminology in the target language. For patient-facing materials, they balance linguistic accuracy with cultural sensitivity and plain-language accessibility.

If you have a medical translation project, a one-off document or an ongoing multilingual documentation programme, contact us for a free quote. We’ll match you with translators who know your specific sector.

Medical Translation Services Case Studies

Category: Medical Translation Services
Description: Written Translation
Client: Interact Medical

Size of project: Ongoing translation – daily projects

Interact Medical is a preeminent medical locum agency, revolutionizing the way healthcare professionals and organizations connect. They specialise fulfilment of doctor jobs, nursing agency jobs and all other healthcare locums

We have been providing the translation of criminal record checks, residence proofs, education diplomas and certificates. Each translated document includes our Certificate of Accuracy, guaranteeing its accuracy and quality.

Category: Medical Translation Services
Description: Written Translation & Multilingual Voiceover
Client: Shire Plc.

Size of project: 2,000 words script and voiceover recording

The Shire team was intent on raising awareness for Fosrenol, so they created an animation to showcase how the medication can be used optimally. This animated video was specifically crafted for healthcare providers and contains technical medical language.

Our team crafted a translation of the script with precision and care, and we recorded the multilingual voiceover for the animation.

Category: Medical Translation Services
Description: Written Translation into French, German, Spanish, Italian and Brazilian Portuguese
Client: Shire Plc.

Size of project: 40,000 words 

When the Shire team were working on promoting their drug Equasym, they needed to translate an extensive manual on how to best use the drug. The manual was aimed at medical professionals and was using medical jargon.

Category: Medical Translation Services
Description: Written Translation into French, German, Spanish and Italian.
Client: Celgene Corporation

Size of project: 110,000 words 

Celgene needed an expert e-learning program translation to ensure accuracy and clarity. Our medical translators ensured that not only was the translation accurate and free-flowing but also effectively operated within the client’s e-learning platform.