Medical device manual translations are essential for any medical device manufacturer looking to bring their product to a new international market. Medical device manuals are critical documentation that outlines 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 vital information to be accurately conveyed so that users of medical devices can correctly and safely focus on deploying machines, devices, and apparatuses that treat, diagnose, and prevent diseases. Medical device documentation must be translated accurately and with fast turnaround times to gain regulatory approval, effectively compete in overseas markets, and ensure patient safety.
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 integral to 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 as a medical device. To deploy these medical devices and improve healthcare systems, providing high-quality and accurate translations for medical device software is also a meaningful 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 our software localization services for medical devices.
Regulatory Translations for Medical Devices Manuals
Meeting regulatory standards and compliance with global regulations is essential for gaining market access throughout the life sciences industry, especially the medical devices industry. Many international 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 about the safety, use, and efficacy of medical devices and often require medical device manuals to be submitted for approval. CSOFT Health Sciences offers accurate and timely translations for medical device manuals and medical device documentation data to ensure compliance with global regulatory standards.
Learn more about regulatory translations for medical device manuals.
Medical Device Document Translations
The medical device development and approval process can be lengthy and require manufacturers to submit various 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 to meet regulatory standards for all medical device development lifecycle stages. With a growing demand for medical devices overseas, manufacturers must ensure that medical device documentation is translated accurately and promptly.
Learn more about our medical device document translation services.
Implantable Medical Device Translations
As technological innovation and growing demand in the international market space drive 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 fit 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.
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 the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.
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 at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
