Medical Device Translation Services, Medical Device Submissions, IFU, DSURs, SUSARs

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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

What our Clients say

Director, Regulatory Affairs,

US based leading precision medicine company

We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

Director, Regulatory Affairs,

US based leading precision medicine company

Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.

Regulatory Affairs Officer

A Global Industry Leader in Medical Device Design and Manufacturing

You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!

Associate, Regulatory Affairs Team II,

Clinical & Regulatory Affairs Center,
A Korean Chemical Company

Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

Manager, Regulatory Affairs

A Spanish Medical Devices Manufacturer

Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

Director, Regulatory Affairs

US based top Sterilization company

The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

Translation Support

Overview

Freyr Expertise

Freyr Advantages

Director, Regulatory Affairs,

Director, Regulatory Affairs,

Regulatory Affairs Officer

Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

Let’s connect

We’re here to help and answer any question you might have.
We look forward to hearing from you.

GET IN TOUCH

Call us

USA

UK

GERMANY

INDIA

More Locations

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Translation Support

Overview

Freyr Expertise

Freyr Advantages

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What our Clients say

Director, Regulatory Affairs,

Director, Regulatory Affairs,

Regulatory Affairs Officer

Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

Let’s connect

We’re here to help and answer any question you might have. We look forward to hearing from you.

GET IN TOUCH

Call us

USA

UK

GERMANY

INDIA

More Locations

Email us

We’re here to help and answer any question you might have.
We look forward to hearing from you.