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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.

Implantable Medical Device Translations

As technological innovation and a growing demand in the international market space drives medical device manufacturers to compete overseas, implantable medical device translations for the materials and content necessary for researching, developing, and approving new devices. A specific type of medical device, implantable medical devices and active implantable medical devices (AIMDs) are placed in the body during clinical intervention or surgery and fits into the US Food and Drug Administration’s (FDA) Class I, Class II, and Class III (low-high risk) medical device classifications. Throughout the product’s lifecycle, high volumes of documentation are required to move the device from the manufacturing phase to the clinical trial phase and to be approved by regulators. To help companies reach new markets and patients globally, CSOFT Health Sciences provides cost-effective implantable medical device translations with fast project turnaround times, for all phases of development and market approval.

Learn more about our implantable medical device translations.

ISO-certified Academic Translations

Data Security

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.

Learn more about how CSOFT protects companies’ data.

Quality Assurance

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.

Learn more about our quality assurance process.

High Quality Academic Translations

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