Medical Device & IFU Translation Services for MDR, IVDR & Global Compliance
Certified medical device translations by professional human linguists with expertise in regulatory compliance. Trusted for IFUs, labeling, software, and technical documentation. ISO 17100 compliant — in over 100 languages.
Certified Medical Device Translations in 100+ Languages
GTS provides a wide range of medical device translation services in English, German, Spanish, Italian, French, Chinese, Japanese and over 100 other languages.
GTS provides specialized medical device and IFU translation services for manufacturers, CROs, and healthcare organizations that need compliant, regulator-ready documentation in 100+ languages.
- Translations aligned with MDR, IVDR, FDA and other global regulatory requirements
- Expert linguists specializing in medical devices, UDI, IFUs and technical documentation
- Accurate formatting for tables, symbols, labeling and device packaging
- Fast turnaround for updates, revisions and multi-language rollouts
- ISO 17100–certified workflows trusted by leading manufacturers and CROs
- Confidential, secure document handling for regulated content
Translation Requirements for Medical Devices & IFUs
Regulatory authorities around the world require that medical device documentation be available in the local language of the markets where the device is sold. In the United States, the FDA mandates English labeling and instructions for use, and requires accurate translations when devices are marketed in non-English speaking regions. In the European Union, the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Regulation (IVDR) require that labels and IFUs be translated into the official languages of each member state where the device is distributed.
Similar requirements apply in other regions. Health Canada requires bilingual (English and French) labeling, while regulators in Japan, China, Brazil and many Latin American and Asian markets require device documentation in the local language. Non-compliance with translation requirements can delay approvals, block market entry or trigger corrective actions.
Working with an experienced medical device translation provider is therefore not only a regulatory necessity, but also a critical part of protecting patient safety and ensuring correct use of your devices worldwide.
Language Requirements Under MDR and IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers are required to provide labels, IFUs, and safety information in the official language(s) of each EU Member State where the device is made available. These language requirements apply not only to end-user instructions, but also to labeling, packaging, and certain technical documentation reviewed by Notified Bodies and competent authorities.
Accurate, regulator-ready translations are therefore essential to ensure conformity assessments, market approvals, and ongoing compliance across multiple jurisdictions. GTS supports medical device manufacturers with consistent, compliant translations tailored to the linguistic and regulatory requirements of each target market.
Certified Medical Device Translation Quality
GTS is a leading provider of medical device translation services. Our quality management system is certified as compliant with the ISO 17100:2015 standard for translation services. All translations are delivered with a signed Certificate of Accuracy, and validated back-translation can be provided when required by regulatory authorities or internal QA procedures.
Medical device projects are handled only by professional translators with proven expertise in medical terminology, device technology and regulatory documentation. Every project is reviewed by a second linguist, ensuring consistent, regulator-ready language across all markets.
Structured Translation Workflow for Regulated Medical Device Content
Medical device translations are managed using a structured, ISO 17100–certified workflow designed for regulated documentation. Each project follows a controlled process to ensure terminology accuracy, formatting consistency, and regulatory readiness.
- Project intake and document analysis
- Terminology review and glossary alignment
- Translation by subject-matter expert linguists
- Independent review by a second qualified translator
- Technical formatting and layout verification
- Final quality assurance checks prior to delivery
This approach ensures that translated IFUs, labels, and technical files are consistent across
languages and suitable for regulatory submission, audits, and global product rollouts.
We Translate All Medical Device Documents
We are a leading provider of medical document translation services and support medical device companies across the entire product lifecycle. Typical document types include:
- IFUs (Instructions for Use) and DFUs (Directions for Use)
- Labels, cartons and packaging content
- UDI, GUDID and EUDAMED submissions and related content
- Installation, operation and maintenance manuals
- Risk management documentation (ISO 14971)
- Clinical evaluation reports (CERs) and clinical study materials
- Post-market surveillance and vigilance documentation
- Technical files and declarations of conformity
You can also access a reference page with free translations of the most common EN 980:2008 symbols used
in medical device IFUs.
Click here to view EN 980:2008 symbol translations.
A Proven Track Record in Medical Device Translation
GTS has completed medical device translation projects for some of the world’s leading manufacturers and healthcare companies. Our customers include Boston Scientific, Siemens, Medtronic, Johnson & Johnson, Novartis and Dentsply International.
Recent medical device translation projects include:
- Translation of IFUs and labels into over 26 languages for Simplivia
- Translation of IFUs into 10 languages for Riverain Technologies
- Translation of IFUs into French and Italian for BrainsWay
- Translation of CIP (Clinical Investigation Plan) and ICFs into Spanish for Embrace Medical
- Translation of IFUs into French, Spanish, Italian, German and Norwegian for Paragonix Technologies
- Translation of IFUs into European Portuguese and French for Energist
- Translation of IFUs into French, German, Italian, Spanish, Portuguese, Turkish, Danish, Latvian, Polish, Slovenian, Swedish, Dutch, Lithuanian, Norwegian and Slovak for Walgreen Health Solutions
- Translation of IFU into French, Italian, German and Spanish for Flat Medical
- Translation of IFU into 4 languages for Soterix Medical.
Get a Quote for Medical Device Translation
Upload your IFUs, manuals, labels or other device documentation to get an instant online quote and turnaround time. A GTS project manager will review your files and ensure that your translation is set up for full regulatory compliance in every target market.
GET PRICE QUOTE FOR MEDICAL TRANSLATION SERVICES
Quotes are obligation-free. Your documents are handled securely and reviewed only for the purpose of preparing an accurate translation estimate.