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’s team of experienced medical language translators and editors can assist you creating error-free translations abiding to context of the targeted regional language. A quality management system with full compliance to ISO 17100:2015 and ISO 9001:2008 standards is a testament to the technical expertise at Freyr. 

Freyr Expertise

  • Instructions for use (IFU)
  • Development safety update reports (DSURs)
  • Medical device operation, maintenance and installation manuals, instruction and user guides
  • Manufacturing process descriptions
  • Product catalogs
  • Suspected unexpected serious adverse reactions (SUSARs)
  • Clinical training materials
  • Package inserts and labels
  • Brochures and web content
  • Regulatory compliance documents for European union and Asian countries
  • 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

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