Select Page

IFU Translations

CSOFT’s instructions for use (IFU) translations help life science companies expand internationally with confidence.

Contact us now
Home 9 IFU Translations

Instructions for use, also known IFUs, are informative labelling for patients that are found on medical devices and pharmaceutical products, making IFU translations an important requirement for many medical products growing in multilingual markets. An IFU gives instructions on how to properly use a medical device (including class I, II, and III medical devices), in-vitro diagnostic device (IVD),  or pharmaceutical products, and gives notice of any precautions associated with using the medicine or device. The information included in an IFU helps to provide guidance on the proper use of a medication or device. It also serves to inform patients of any necessary precautions they should take. An IFU, patient label, or medication guide is especially useful when a pharmaceutical drug has complex dosing instructions.

As the world has become increasingly digital, IFUs have evolved as well. A new IFU format is the electronic information for use, or eIFU. eIFUs contain audio and video files that enable life science companies to more effectively demonstrate how to correctly handle products such as medical products. Electronic information for use is already becoming a regulatory requirement in many parts of the world. For instance, the European Union now requires life science companies to use eIFUs.

Smarter IFU translations

For life science companies expanding overseas, highly accurate and timely IFU translations are vital since most regulatory agencies (such the FDA, EMA, NMPA) require IFUs and eIFUs to be translated into the market’s primary language before gaining market approval. Failing to provide an accurate IFU or eIFU translation can result in loss of market access, negative brand impact, and even legal consequences like fines, lawsuits, and imprisonment. CSOFT’s global network of 10,000+ in-country linguists and subject matter experts, along with our quality assurance process and video translation services, provides life science companies with high quality and timely IFU and eIFU translations to ensure regulatory compliance and the best ROI.

Package Label and Insert Translations

With a growing demand for medical devices and pharmaceutical products to treat patients across the globe, package label and insert translations are essential to meet labeling regulatory demands. Advancements in pharmaceutical products have allowed patients to maintain the quality of a healthy lifestyle and to protect global public health. To access foreign markets, CSOFT Health Sciences ensures regulatory compliance while providing the highest-quality package label and insert translation and localization solutions across 250+ languages.

Learn more about our package label and insert translations.

Improving care through IFU translations
Genetic disease translations

Regulation and Legislation Translations

Regulation and legislation translations are crucial to ensure medical devices and pharmaceutical products are safe and high-quality for patients across the globe. Whether you are a pharmaceutical company, medical device company, U.S Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulations and legislations ensure safety of product use such as drugs, vaccines, biological medical products, and medical devices. To help life science companies maintain high quality and safe products for the targeted audience, CSOFT’s global network of 10,000 linguists and subject matter experts provide accurate and timely translations for a complete range of content, materials, and documents for life science companies.

Learn more about our regulation and legislation translations.

Quality Assurance

CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.

Learn more about how CSOFT prioritizes data security.


Speak to one of our support agents.