In-Vitro and Medical Device Translation

Improve the reach of your medical devices through compliant accurate traslations.

ISO 13485:2016 Certified
Medical Device Translation

We understand the highly regulated nature of the medical device industry and the critical role that translation quality plays in achieving regional and international success. Our experience coupled with certified processes that are also HIPAA compliant ensure we deliver quality while maintaining robust information and data security.

Some of the Medical Device Documents We Specialize in

  • Instructions for Use (IFU)
  • Product Labels and Packaging
  • Patient Information Leaflets (PILs)
  • Clinical Evaluation Reports (CER)
  • Regulatory Submissions
  • Biocompatibility Reports
  • Clinical Trial Protocols
  • Risk Management Documents
  • Notified Body Communications
  • Device Master Files (DMF)
  • Standard Operating Procedures (SOPs)
  • Technical Manuals
  • Patent Documents
  • Verification and Validation Documents
  • Post-Market Surveillance Reports
  • Training Materials
  • Quality Management System (QMS) Documents

Country Specific Regulatory Compliance

  • The European Union
  • Food and Drug Administration (FDA) 
  • Medical Device Reporting (MDR)
  • International Conference on Harmonization (ICH) 
  • Therapeutic Goods Administration (TGA)
  • In vitro Diagnostic Medical Devices Regulation (IVDR)

Our Key Contributions to the Life Science Industry

Medical Device Translations
You Can Trust

We've designed our localization experience with certified processes and efficient technology, ensuring a seamless delivery of consistent quality that enhances client satisfaction.

Specialized Subject-
Area Matching

Driven Technology

24x7 Dedicated
Localization Manager

Localization Solutions

In-House Expertise

ISO-Certified Processes






Language Experts


Clients Worldwide

Medical Device Translation Accuracy Enhanced by Subject Matter Experts

We assign translators that are in-field specialists in your specific domain and understand the intricacies of the target language. Each translator possesses a Ph.D. or Master's degree in the relevant subject, along with years of extensive translation experience. Our rigorous standards contribute to the superior quality of your translated outcomes.

What do our clients say?

Our Translators

Deliver care on a global scale through your medical device


Thought Leadership

Learn how we can improve your localization experience