Medical Device Translation Services – Overview
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 in creating error-free translations that abide to the 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 include both general translation and scientific translation services.
The medical device Regulatory Intelligence framework comprises up-to-date global regulations and Health Authority (HA) standings in multiple Regulatory topics for increased market-specific Regulatory insights. This framework intends to help manufacturers with medical device market access and assists them in staying updated with the dynamic environment.
Freyr, with experts in medical device Regulatory landscapes across the globe, brings forth the best information on HA regulations and regional market scenarios. Freyr caters to comprehensive medical device Regulatory Intelligence services such as ad-hoc Regulatory Intelligence reports, periodic global Regulatory update reports, as well as newsletters corresponding to organizational needs, based on the region and device type.
Medical Device Translation Services
- Translation of Instructions for Use (IFUs).
- Medical device operation, maintenance and installation manuals, and instruction and user guides,
- Descriptions of the manufacturing process.
- 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 and 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 the local language.
- Dedicated local affiliates in multiple countries across the world.
- Cost-effective and timely delivery.
- Expert translators and language specialists to simplify complex technical jargons.
- A qualified team of experts with hands-on experience across all categories of medical devices.
- A customized approach based on the complexity, class, and type of the product involved.
- Services tailored to meet region-specific Regulatory complexities.
- A strong relationship with local agencies of various countries.
- A structured approach to ensure quick market access.
