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.
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.
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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.
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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.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
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As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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