Overview
Overview
Medical Device submissions across the world are dependent on accurate translation of technical information, although regarded last by many. A simple mistake in translation can delay or bring the approval process to a standstill, thereby causing the applicant 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
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
