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Medical Device Translation

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 sales@gts-translation.com.



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max hasson
max hasson
18:10 10 Dec 16
Rapid quote and quick turn around. Fully satisfied with the results.
Gina Davis
Gina Davis
19:28 10 Aug 16
Loved the service and turnaround time with this company. They quickly got to know our needs (specifically for a back translation and validated translation for a research project with two languages), and though we inundated them with several additional requests through the project, all was handled professionally and with ease. Highly recommend.
John-Paul McMahon
John-Paul McMahon
15:01 17 Nov 16
A fantastic service and great staff. I am very pleased. They were the best translators that I have worked with.
Mark McKinnon
Mark McKinnon
18:44 07 Dec 16
Quick, efficient translation service who took my requirements and context into account. Would recommend.
Carlos Maza
Carlos Maza
11:35 23 Oct 16
Great customer service and fulfillment of agreed timelines. Very personal service. Would highly recommend them!
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