The medical device sector (also known as the medical technology industry) focuses on medical technology that consists of machines, devices, and apparatuses that treat, diagnose, and prevent diseases, meaning that medical device translations are essential for reaching new patients and global markets. Gaining the competitive advantage in a global industry currently valued at over 400 billion US dollars means that each step of the device’s lifecycle, from manufacturing to regulation and oversight, requires detailed documentation that may be specific to certain markets. To gain regulatory approval, effectively compete in overseas markets, and ensure patient safety, medical device documentation such as instructions for use (IFU) and package inserts and labels must be translated accurately and with fast turnaround times. With a global network of 10,000+ in-country linguists and subject matter experts (SMEs), CSOFT Health Sciences provides medical devices’ manufacturers with highly accurate and timely medical device translation services in 250+ languages, including all kinds of medical document translations, medical software translation and localization, and medical eLearning and training translations.
In addition, CSOFT Health Sciences offers translation and localization solutions for a full range of medical devices, including:
- Medical Testing Devices and Implants Translations
- Prostheses and Orthopedic DeviceTranslations
- In Vitro Diagnostic (IVD) Devices Translations
- Class I, Class II, and Class III Medical Devices (Low-risk and High-risk Devices) Translations
- Reusable Surgical Instruments Translations
- Active Implantable Medical Devices Translations
- Medical Device ComponentsTranslations
EU MDR Translations
In May 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) was replaced and in now fully covered by the Medical Device Regulation (MDR). The MDR brings many new changes, especially changes to medical device labelling and language requirements to gain EU MDR compliance. This has created new challenges for medical device manufacturers attempting to gain market access to EU’s diverse market. With all these new changes, it is important for medical device manufacturers to establish a partnership with a language service provider (LSP) that is certified in ISO 13485:2016 and has an in-depth understanding of the new EU MDR to ensure there are no delays for medical device products entering EU’s market. With proven experience working with the medical device industry, CSOFT Health Sciences provides MDR regulatory translations to help companies meet the EU’s standards for bringing medical devices to market.
Learn more about our European Union Medical Device Regulation (EU MDR) translations.
Software as a Medical Device (SaMD) Translations
In the medical field, software has a growing place in accelerating our ability to discover, manage, and treat all types of conditions, which makes Software as a Medical Device (SaMD) translations essential for integrating this technology into global medical markets. By US Food and Drug Administration (FDA) standards, SaMD is any software that carries out medical functions without the need of actual hardware. As a relatively new field within healthcare, SaMD plays a specific role, such as the software used to control the motors of an infusion pump or the software that enables medical communications, including video calling, scheduling appointments, and digital patient registration. More broadly, the applications of SaMD platforms include diagnosing and screening, monitoring and alerting, disease and condition management, and digital therapeutics. As SaMD platforms continue to advance, the global integration of this technology demands that the materials and content necessary for driving this growth be available in any language and tailored to the needs of any market. To help companies safely and efficiently bring this technology overseas, CSOFT Health Sciences provides Software as a Medical Device (SaMD) translations in over 250 languages.
Learn more about our SaMD translations.
Medical Device Document Translations
The medical devices development process requires medical device manufacturers to submit a variety of medical device documents including documents for regulatory submissions, patents and international business agreements, instructions for use (IFU), manufacturing process descriptions, package inserts and labels, phase 0-IV clinical trial documentation, post-market safety reporting, CE marking technical files, operation procedures, and more. As the demand for medical devices shifts overseas, manufacturers must ensure that translations of each medical device’s documentation is done accurately and in a timely manner. CSOFT Health Sciences specializes in end-to-end translations for medical device documentation across all stages of the medical device development lifecycle.
Learn more about our medical device document translation services.
Medical Software System Guidance Translations
Medical software system guidance translations are imperative to ensuring the success and regulatory compliance of medical software products and services in overseas markets. Product-specific guidance statements are issued by the US Food and Drug Administration (FDA) and describe the agency’s current thinking on how to safely and effectively develop new products, therapies, or devices. Medical software systems play a crucial role in healthcare today and providing the correct documentation in the languages required for regulatory approval is critical for patients and healthcare systems globally. CSOFT Health Sciences specializes in high quality translations for medical software system guidance in 250+ languages.
Learn more about our medical software system guidance translations.
Medical Device Manual Translations
Safely and properly operating medical devices to deliver precision care requires an in-depth understanding of the different components, operating systems, and mechanical features of these devices. Medical device manuals are technical documents that outline the procedures, instructions, protocols, and schematics pertaining to all types of medical devices. Especially when selling medical devices to international markets or training new staff on how to operate these devices, it is essential that all personal are able to fully understand the manual without language functioning as a barrier to communication. Whether translating manuals to gain regulatory compliance or translating manuals to educate staff and suppliers on operational procedures, CSOFT Health Sciences provides end-to-end medical device manual translations in 250+ languages.
Learn more about our medical device manual translations.
Mobile Medical Application Translations
As the medical devices and medical software markets continue to grow, mobile medical application translations enable companies to expand their operations globally and reach new markets. Mobile applications are becoming an increasingly central feature in most industries, and the use of this technology in the medical field is opening new and innovative opportunities to improve health and accurate patient health data. Through mobile medical applications, patients are able to monitor their health data and gather health metrics in real-time, which has opened the door to a growing demand for localizing these platforms and translating content. To help medical application developers tailor their technology to new patients across a wide range of languages, CSOFT Health Sciences provides end-to-end translations for mobile medical applications.
Learn more about our mobile medical application translations.
eLearning and Training Translations
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. As the demand for medical devices grows overseas, providing highly accurate and culturally appropriate translated eLearning and training materials is essential for regulatory compliance and quality assurance. CSOFT Health Sciences provides eLearning and training translation and localization solutions to maximize product reach and ensure safe medical device operation across multiple markets. In addition, CSOFT offers video translation services such as multilingual video voiceover, subtitling, and dubbing.
Learn more about our eLearning and training translation services.
Regulation and Legislation Translations
Regulation and legislation translations are implemented to ensure compliance and to provide safe and high-quality services to clients. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you are a pharmaceutical company, medical device company, US 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, medical devices, and radiation-emitting products. As companies and organizations continue to release products into new markets and reach customers throughout the world, keeping up with regulations and legislations is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulations and legislations. With a global network of in-country linguists and expertise to translate over 250 languages, we can help localize your regulations and legislation needs.
Learn more about our Regulation and Legislation Translations
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.
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.