Medical Device Manual Translations

Medical device manual translations are highly important for the integration of medical technology into healthcare systems and emerging markets seeking to expand the deployment of cutting-edge medical devices.

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Medical device manual translations are important for any medical device manufacturer looking to bring their product to a new international market. Medical device manuals are a critical piece of documentation that outline the intended use, intended purpose, instructions, and other general information on the medical device as presented by the manufacturer. The medical device sector relies on this important information to be accurately conveyed so that users of medical devices can correctly and safely focus on the deployment of machines, devices, and apparatuses that treat, diagnose, and prevent diseases. To gain regulatory approval, effectively compete in overseas markets, and ensure patient safety, medical device documentation must be translated accurately and with fast turnaround times.

With a global network of 10,000+ linguists and subject matter experts in areas including biotechnology translations, hospital translations, and clinical trial translations, CSOFT offers a full range of localization solutions for medical device manual translations, including:

Software Localization for Medical Device Manuals

Software has become an integral part of medical devices and medical technology throughout the life sciences industry. Beyond Software in Medical Device (SiMD) products such as X-rays and CT scans, there is a growing deployment of Software as a Medical Device (SaMD), which is essentially software that acts a medical device itself. To deploy these medical devices and improve healthcare systems, providing high quality and accurately translations for medical device software is also an important way to gain regulatory approval for medical devices in overseas markets. CSOFT Health Sciences utilizes a network of 10,000+ linguists and experts in subject matter to provide translation solutions medical device software and medical device manuals to help ensure market success.

Learn more about software localization for medical devices.

Regulatory Translations for Medical Devices Manuals

Throughout the life sciences industry and especially the medical devices industry, meeting regulatory standards and being in compliance with global regulations is essential for gaining access to markets. Many global regulatory bodies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China’s National Medical Products Administrations (NMPA) have strict requirements for documentation pertaining to the safety, use, and efficacy of medical devices and often require medical device manuals to be submitted for approval. To ensure compliance with global regulatory standards, CSOFT Heath Sciences offers accurate and timely translations for medical device manuals and medical device documentation data.

Learn more about regulatory translations for medical device manuals.

Medical Device Document Translations

The medical devices development and approval process can be lengthy and requires medical device manufacturers to submit a variety of specialized medical device documents. From translations for regulatory submission documents to translations for patents and international business agreements, medical device manufacturers must rely on the correct documentation that can meet regulatory standards for all stages of the medical device development lifecycle. With a growing demand for medical devices overseas, manufacturers must ensure that translation of medical device documentation is done accurately and in a timely manner. CSOFT Health Sciences specializes in end-to-end translation for medical device documentation and medical device manual across 250+ languages.

Learn more about our medical device document translation services.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

 Quality Assurance for Alanian translations
Data security

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 and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

Learn More About Our Medical Device Manual Translations!