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Translation Support

Overview

Overview

Although, relegated to the last by many Medical Device companies, Medical Device submissions across the world are dependent on accurate translation of technical information. A simple mistake in translating can delay or bring the approval process to a standstill, thereby causing the applicant a loss of time and resources impacting the overall costs for companies.

With technical writing expertise and proficiency in 100+ global languages, Freyr provides medical device translation services with a team of experienced medical language translators and editors who can assist you creating error-free translations abiding to context of the targeted regional language. A Quality Management System (QMS) with full compliance to ISO 17100:2015 and ISO 9001:2008 standards is a testament to the technical expertise at Freyr. Freyr’s Medical Device Translation Services includes both General Translation and Scientific Translation Services

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Instructions for Use / IFU Translation
  • Medical Device operation, maintenance and installation manuals, instruction and user guides
  • Manufacturing Process Descriptions
  • Product catalogues
  • Clinical training materials
  • Package inserts and labels
  • Brochures and web content
  • Regulatory compliance documents
  • Informed consent forms for clinical trials
  • Validated back translation and sworn translations in certain countries
  • Localization of Medical Device software, translation of resource files
  • Software application interfaces and documentation
  • Patents for medical and surgical devices
  • General and Scientific Translation
  • Translation of Agency guidelines published in local languages
Advantages

Freyr Advantages

  • Dedicated local affiliates in multiple countries across the world
  • Cost-effective and timely delivery
  • Expert translators and language specialists to simplify complex technical jargon
  • Qualified team of experts with hands-on experience across all categories of Medical Devices
  • Customized approach based on the complexity, class and type of the product involved
  • Services tailored to meet region-specific Regulatory complexities
  • Strong relationship with local agencies of the countries
  • Structured approach to ensure quick market access