Medical Device Translation Services

GTS provides a wide range of medical device translation services in English, German, Spanish, Italian, French, Chinese, Japanese and over 100 other languages.

Do you want a price quote for professional translation of an IFU, a medical device manual or other related medical device documents? Click here to get an instant online price quote and get started on your translation project today.

Translation of Medical Device Documents-Requirements and Standards

Regulatory requirements and standards for medical device translation, as established by organizations like the FDA in the United States and the EMA in Europe, play a crucial role in ensuring the safety and effectiveness of medical devices. In the United States, the FDA mandates that all medical devices sold must have English labeling, instructions for use, and relevant information. Additionally, if these devices are sold in non-English speaking areas, accurate translations are necessary. Similarly, the European Union’s Medical Device Regulation (MDR, Regulation (EU) 2017/745) requires that medical devices marketed in the EU have labels and instructions translated into the official languages of the member countries where they are sold, ensuring that healthcare professionals and consumers can use these devices safely.

This emphasis on accurate and clear translations is also echoed in other regions like Asia and Latin America. For instance, Canada requires bilingual labeling in English and French, and countries such as Japan, China, and Brazil necessitate translations into their respective languages. Non-compliance with these translation requirements can lead to regulatory actions, including the refusal to approve a medical device for market entry. Thus, adhering to translation standards is not just about regulatory compliance; it’s a vital aspect of ensuring patient safety and effective healthcare delivery globally.

Certified Medical Device Translation

GTS’s commitment to quality is well known in the industry. Our quality management system is certified as compliant with the ISO 17100:2015 standard. All translations are provided with a certificate of accuracy. If required by regulatory authorities, we can also provide validated back translation.

We translate all medical device documents

We are a leading provider of medical document translation services. We translate the following types of documents and materials for medical device companies:

• IFUs (Instructions for Use)
• Medical device Operation Manuals, Instruction and User Guides
• Product Catalogs
• Clinical Training Materials
• Brochures and web content
• Informed Consent Forms for clinical trials
• Localization of medical device software, translation of resource files

Click here to access a page with free translations of the most common EN 980:2008 labels used in medical device IFUs.

A Proven Track Record in Medical Device Translation Projects

GTS has completed translation projects for some of the world’s leading medical device companies. Customers include Boston Scientific, Siemens, Medtronic, Johnson and Johnson, Novartis and Dentsply International.

Here are some recent projects that we have done for medical device companies:

• Translation of IFUs into over 20 languages for Qualimed
• Translation of IFUs and labels into over 26 languages for Simplivia.
• Translation of IFUs to 10 languages for Riverain.
• 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.