Medical Device Translation
Translation plays a key role for companies that wish to sell medical devices internationally. Many countries have their own regulatory and safety requirements, and require translation of a wide range of documents and labeling into the local language. Pre-market approval must usually be obtained from the regulatory authorities in that country.
GTS provides a wide range of medical device translation services in English, German, Spanish, Italian, French, Chinese, Japanese and over 50 other languages. Our quality management system has been audited and found to be in full compliance with the ISO 17100:2015 and ISO 9001:2008 standard. We provide translation Certificates of Accuracy upon request. If required by regulatory authorities, we can provide validated back translation and sworn translations in certain countries.
We translate the following types of 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, Cochlear, Dentsply International and many others.
Here are some projects we have done recently:
- Translation of Siemens Hearing Aids website to Danish, Swedish and Norwegian
- Translation of IFU (Instructions for Use) to 14 languages for Thompson Medical
- Translation of Clinical Study documents into French, German, Norwegian and Dutch for Dentsply
- Translation of medical device operation manuals into 8 languages for Lumenis
- Translation of website into 7 languages for Premia Spine
Price Quotes for Medical Device Translation Services
Need a price for an IFU, a medical device manual or other related documents? Use the quote form on this page or send an email with your project requirement to firstname.lastname@example.org.