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. 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 provides medical devices’ manufacturers with highly accurate and timely medical device translation services in 250+ languages, including all kinds of medical document translation, software translation and localization, and eLearning translations.
- Medical Testing Devices and Implants
- Prosthesesand Orthopedic Devices
- In Vitro Diagnostic (IVD) Devices
- Class I, Class II, and Class III Medical Devices (Low-risk and High-risk Devices)
- Low-risk and High-risk Devices
- Reusable Surgical Instruments
- Active Implantable Medical Devices
- Medical Device Components
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) will be replaced to and 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 will create 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.
Learn more about our European Union Medical Device Regulation 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 translation of each medical device’s documentation is done accurately and in a timely manner. CSOFT Health Sciences specializes in end-to-end translation for medical device documentation across all stages of the medical device development lifecycle.
Learn more about our medical device document translation services.
Medical Device 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). Beyond software in medical device hardware, in the past decade, there has been a prominent trend called Software as a Medical Device (SaMD), referring to software that performs medical functions itself, such as software that enables patients to use their phones to look at MRI scans. To gain regulatory compliance and stay competitive in overseas markets, medical device manufacturers must ensure accurate translation of all software components. 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 medical device software applications for medical device companies.
Learn more about our medical device software translation and localization services.
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 materials is essential for regulatory compliance and quality assurance. CSOFT provides eLearning 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 translation services.
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 compliant with ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
Learn more about how CSOFT protects your data.