GTS provides professional IFU and DFU translation services for medical device manufacturers, CROs, and healthcare organizations that require accurate, regulator-ready documentation for global markets.

• IFU translations aligned with MDR, IVDR, FDA, and global regulatory requirements
• Medical device linguists experienced in regulated technical documentation
• Accurate formatting for tables, symbols, warnings, and step-by-step instructions
• Fast turnaround for revisions, updates, and multi-language rollouts
• ISO 17100–certified workflows for regulated medical content
• Secure and confidential handling of all documentation

Specialized IFU Translation for Medical Devices

Instructions for Use (IFUs) and Directions for Use (DFUs) require precise, standardized language to ensure correct device operation, patient safety, and regulatory compliance. GTS translates IFUs using approved medical terminology covering indications for use, contraindications, warnings,
precautions, step-by-step operating instructions, cleaning and reprocessing guidance, symbols, and safety statements.

Our translators are experienced with IFU-specific terminology, including device functionality, risk-related language, human factors considerations, and standardized medical symbols commonly used in regulated medical device documentation.

IFU Translation for a Wide Range of Medical Devices

We translate IFUs and DFUs for a broad spectrum of medical devices, from single-use consumables to complex electromechanical systems, including:

• Implantable devices and surgical implants
• Syringes, catheters, and disposable medical consumables
• Diagnostic and patient monitoring devices
• Electromechanical and software-driven medical equipment
• Capital equipment used in hospitals and clinical settings
• Home-use and professional-use medical devices

Each IFU is translated with careful attention to device-specific instructions, safety warnings, symbols, and layout requirements to ensure clarity and usability in every target language.

Certified Medical Device IFU Translation

GTS operates under an ISO 17100:2015-certified quality management system. All IFU translations are completed by qualified medical device linguists and independently reviewed by a second professional translator to ensure accuracy, consistency, and regulatory readiness.

Translations are delivered with a signed Certificate of Accuracy. Validated back-translation can be provided when required by regulatory authorities or internal QA processes.

Click here to access a page with free translations of the most common EN ISO 15223-1:202 labels used in medical device IFUs.

Localization of Medical Device Software

Most IFUs have screen shots of the medical device user interface (UI). GTS can translate the UI and insert the localized screen shots into the IFU.

IFU Translation Compliance (MDR Annex I & ISO 17664)

Under the EU Medical Device Regulation (MDR), Annex I requires that IFUs, labels, and safety information be provided in the official language(s) of each Member State where a medical device is made available. These language requirements apply to both professional-use and lay-user documentation and are critical to conformity assessment and market access.

In addition, IFUs for reusable medical devices often include cleaning, disinfection, and sterilization instructions. Where applicable, ISO 17664 specifies requirements for information supplied by the manufacturer for processing reusable medical devices. Accurate translation of reprocessing instructions is essential to support safe use and reduce regulatory and patient safety risks.

GTS supports medical device manufacturers with IFU translations that reflect these regulatory and standards-based requirements across all target markets.

Page Layout of IFUs

Many translated IFUs are published with all of the translations in one booklet or leaflet. This can be as many as 26 languages. While this is often not the case for large IFUs (e.g., 100 pages or more), it is very often the case for IFUs of up to a few thousand words. GTS can provide page layout of multi-language IFUs in compliance with EN ISO 15223-1:202 requirements. This includes insertion of the correct IFU symbols.

A Proven Track Record in Medical Device Translation Projects

GTS has completed translation projects for some of the world’s leading medical device companies. Here are some sample projects.

• Translation of IFUs into over 20 languages for Qualimed
• Translation of IFUs into 26 languages for Simplivia Chemfort products. Languages included Bulgaria, Croatia, Czech, Dansk, Dutch, Estonia, Finnish, French, German, Greek, Hebrew, Hungary, Irish, Italian, Latvian, Lithuanian, Maltese, Norwegian, Polish, Portuguese, Romanian, Serbia, Slovak, Slovenian, Spanish, Swedish
• Translation of IFUs into 14 languages for Walgreen Health Solutions. Languages included Danish, Dutch, French, Italian, Latvian, Lithuanian, Polish, Portuguese (Portugal), Romanian, Russian, Slovak, Slovenian (Slovene), Spanish (European), Swedish and Turkish.
• Translation of IFUs into French and Italian for Brainsway
• Translation of IFUs to Dutch, French and Italian for Medical Targeting Technologies GmbH
• Translation of IFUs into over 10 languages for Riverain Technologies, Inc.
• Translation of IFUs into four languages for OrthoFX
• Translation of IFUs into Czech, Dutch, French, German, Greek, Italian, Norwegian, Polish, Portuguese, Spanish and Swedish for Fairmont Medical Products
• Translation of IFUs into four languages for Flat Medical
• Translation of IFUs into French, Italian, German, Spanish, Portuguese, Dutch, Turkish for Premia Spine
• Translation of IFUs for Paragonix Technologies Inc. into Dutch, French, German, Italian, Slovak, Spanish (European), Swedish, Turkish

For full medical device documentation support — including IFUs, labeling, UDI content, technical files, and regulatory materials — see our page on Medical Device Translation Services.