Medical Device Translation Solutions for the Life Sciences Industry

Ensuring Success in the Global Market through Medical Device Translations for a Full Range of Manufacturers

Within the life sciences, medical device translation comprises one of the most quickly growing areas of localization, as world markets furnish new opportunities for growth that also entail complex regulatory pathways manufacturers must navigate across languages. With criteria that vary at the level of economic unions, continents, and nations, bringing medical devices to market overseas requires a well-planned localization strategy with support from a qualified language service provider (LSP) that can offer the local in-country linguistic resources and regulatory knowledge needed to succeed.

The medical device sector (also known as the medical technology industry) focuses on medical technologies used to treat, diagnose, and prevent diseases, encompassing a range of machines, devices, and apparatuses. For medical devices to gain regulatory approval and compete in overseas markets, and to prevent unnecessary patient deaths, documentation such as instructions for use (IFU) and package inserts and labels must be translated accurately and consistently. It is essential that translations meet these requirements both within documents and relative to changing industry norms and standards in target markets, requiring the work of expert linguists with up-to-date knowledge of the field.

With a global network of more than 10,000 in-country linguists and subject matter experts, CSOFT can provide medical device manufacturers with highly accurate and timely medical device translation services. CSOFT understands the regulatory requirements our clients must comply with, and we apply our expertise and experience to help mitigate risk and safety concerns for our clients and their patients.

Medical Document Translation for Medical Device Developers

The medical device development process requires medical device manufacturers to submit a variety of documents including regulatory compliance documentation like NMPA, FDA, and EMA submissions,  legal documents such as patents and international business agreements, instructions for use (IFU), manufacturing process descriptions, package inserts and labels, phase 0-IV clinical trial documentation, and post-market safety reporting. As the demand for medical devices shifts overseas, medical device manufacturers must ensure that documentation at all stages of the medical device development process is accurately translated in a timely manner. CSOFT Health Sciences specializes in end-to-end translation for documentation across all stages of the medical device development lifecycle.

Learn more about our medical document translation services.

Medical Software Translation and Localization

Software is a core component of many medical devices, such as X-Rays, CT scans, and point-of-care (POC) in-vitro diagnostic devices (IVD). In the past decade, Software as a Medical Device (SaMD) has become a prominent trend, referring to software that performs medical functions itself, such enableing patients to use their phones to look at MRI scans. To gain regulatory compliance and be competitive in overseas markets, medical device manufacturers must ensure that software components such as UX/UI strings are accurately translated and localized and arranged in a logical, informative interface. CSOFT has extensive experience in translating software GUI through our localization best practices. Our subject matter experts work closely with our in-country linguists and engineer teams to virtually transcreate all software applications for medical device companies.

Learn more about our software translation and localization services.

Multilingual eLearning Solutions

Medical device manufacturers must ensure that proper training is offered to end-users such as consumers, doctors, and other healthcare professionals on correct use of medical devices. In addition, medical device manufacturers need to train workers on how to correctly assemble and manufacture medical devices complying with regulatory standards. As the demand for medical devices grows overseas, providing highly accurate and culturally appropriate eLearning materials is essential for regulatory compliance and quality assurance.   CSOFT provides eLearning translation and localization solutions to maximize product reach and ensure safe product operation across multiple markets. In addition, CSOFT offers video translation services such as multilingual video voiceover, subtitling, and dubbing.

Learn more about our eLearning translation solutions.

Medical Device Terminology Management

Effective medical device terminology management in the source document saves businesses 20% or more on translation costs. While writers and translators receive specialized training in the medical field, it still takes time to research important terminology during the content development and translation process. Studies find that the number one factor affecting translation quality is the inaccurate and inconsistent use of technical terms specific to a particular industry.

Download our white paper on Terminology Management for the Life Sciences to learn more about how CSOFT can improve your quality while reducing cost.

Quality Assurance

Quality Assurance

Professional, high-quality localization of a service or product is critical for translation solutions in 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 remain in one centralized location, updated in real time, to ensure CSOFT has you covered every step of the way. Additionally, we are certified in ISO 17100:2015ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet global regulatory requirements and our clients’ highest expectations for quality.

Learn more about our quality assurance processes.

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data security processes leverage best practices from ISO 27001, ensuring we adhere to the latest international standards in information security.

Learn more about CSOFT’s data security procedures.

Data Security

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For more information on how CSOFT can assist you with your translation requirements, please contact us through this website, or call us at +1-617-263-8950.

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