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.

ISO 13485:2016 Certified Medical Device Translation

Our Key Projects

Translations done on client's Medical reports related to peripheral vascular disease and hypertension.

Translated client's equipment manual related to contouring in RT-Structure Sets and renaming partial structures according to TG263 standard.

Translated the production report for Upacicalcet sodium hydrate (AJT240 Na), an active pharmaceutical ingredient.

Translated and Transcribed, a clinical project where the client interviewed a set of patients about a particular health issue and their symptoms.

sanofi

High-quality translations were completed on Sanofi's adverse event reports, developed by the Council for International Organizations of Medical Sciences (CIOMS).

alvogen

Translated 121 files of Pharmaceutical and Chemical–Formulation Development and Quality Assurance–Standards and Quality Test Reports for Alvogen.

koru pharma

Translated catalogs for client's various medical solutions that help with treating and maintaining the skin.

eisyes

Translated a Clinical Research Paper related to High-Intensity focused Ultrasound that Decreases Subcutaneous Fat Tissue Thickness by Increasing Apoptosis and Autophagy.

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
  • Training Materials
  • Clinical Trial Protocols
  • Risk Management Documents
  • Notified Body Communications
  • Device Master Files (DMF)
  • Standard Operating Procedures (SOPs)
  • Technical Manuals
  • Biocompatibility Reports
  • Verification and Validation Documents
  • Post-Market Surveillance Reports
  • Quality Management System (QMS) Documents
  • 200+ Languages Translation Service
    200+ Languages
  • 125 Countries
    125 Countries
  • 200000+ Client Worldwide
    200,000+ Clients Worldwide
  • 3000+ Language Expert
    3000+ Language Experts
  • 99.45% Customer Satisfaction
    99.45% Customer Satisfaction

Country Specific Regulatory Compliance

Based on your request, we make sure that your translations comply with global regulatory standards. Additionally, we can format your documents to meet the specific regulations set by different countries, including but not limited to:

  • 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)
Country Specific Regulatory Compliance

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

Quality-
Driven Technology

24x7 Dedicated
Localization Manager

ROI-Driven
Localization Solutions

In-House Expertise

ISO-Certified Processes

Medical Device Translation accuracy enhanced by subject matter experts

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

We've helped many medical clients with the best quality medical translation services. Here's what they have to say about the quality and value we provide.

Deliver care on a global scale through your medical device

CONTACT SALES

Our Memberships

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Frequently Asked Questions

Medical device translation is the process of adapting and translating texts related to the use of medical devices. This encompasses translation of medical device packaging, labeling, user manuals, instructions for use, and more.
Ulatus is an ISO 13485 certified translation company committed to serving the global medical community in over 200 languages. From translating clinical trials to technical medical documents, pharmaceutical materials, and beyond, we address all your needs with precision and expertise.
There are various methods for finding translators, from onboarding in-house experts to hiring medical device consultants. However, if you plan to sell devices internationally, outsourcing your project is ideal. In this scenario, engaging a translation company with several years of experience in your industry is your best option.
Medical device translation involves technical details that can be challenging to understand. Therefore, utmost care is essential to accurately convey these technical details and device features to global medical practitioners.

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