What are In-Vitro Diagnostic Devices?
The In-vitro diagnostic medical devices (IVD) market requires manufacturers to submit a variety of important documentation to meet regulatory standards and safety guidelines, including In-vitro diagnostic medical devices (IVD) translations. IVD are a type of medical device that analyze blood, tissue, and other specimens taken from patients to diagnose diseases, monitor health. In addition to monitoring health, in vitro diagnostic devices are also found in precision medicine, where they are used to find patients who are good candidates to receive new therapies or treatments. Common examples of IVD devices include:
- Next-generation Sequencing Tests
- Pregnancy Tests
- Clinical Chemistry Analyzers
- Urine Test Strips
- Blood Glucose Self-testing
- HIV Blood Diagnostic
- Enzyme-Linked Immunosorbent Assay (ELISA) Kits
- COVID-19 Tests
The rising number of elderly patients is predicted to cause the IVD medical device market to shift from North America to overseas. With this shift, the need to provide high-quality and accurate IVD medical device translations, are vital for gaining regulatory compliance to sell IVD products in foreign markets. With a global network of subject matter experts and over 10,000 in-country native linguists, CSOFT offers highly-accurate and timely IVD translation solutions for IVD content such as instructions for use (IFU), package inserts, IVD labels on-device software, eLearning videos in 250+ languages.
In-Vitro Diagnostic Device Translations Solutions
Multiple international regulatory bodies demand that IVDs are clearly labelled to guarantee patient safety and proper use. When IVD products are sold in foreign markets, they must be translated into the target market’s official language(s) to meet regulatory demands. Because regulatory requirements are often strict, IVD labels must be translated with a high degree of accuracy; failing to do so can lead to delayed market access, resulting in millions in lost revenue. CSOFT’s team of subject matter experts and global network of over 10,000 linguists can provide IVD diagnostics companies with highly-accurate and timely translation and localization of IVD medical device documentation in 250+ languages.
Learn more about our IVD medical device translation solutions.
Multilingual IVD Clinical Trial Translations
Today, a growing number of clinical trials are conducted globally, with upward of 90 percent of new drugs approved in 2017 undergoing trials and testing outside their primary markets. As the demand for IVD medical devices shifts overseas, accurately translated and culturally appropriate clinical trial documentation and patient recruitment material is vital for successful clinical trials. From contract research organizations (CROs) and sponsors to institutional review boards and clinics, CSOFT’s 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help IVD companies achieve international compliance through highly accurate clinical trial translations. CSOFT translates all types of IVD clinical trial documentation, from clinical study protocol and informed consent forms to clinical study reports and AEs/ARs/SAEs/SARs/SUSARs
Learn more about our clinical trial translation services.
Point of Care IVD Software Translation and Localization
Point-of-care IVD medical devices allow for remote testing at patient care sites such as patient homes, enabling healthcare professionals to receive real-time test results. To market such IVD point-of-care testing (POCT) devices internationally, POC IVDs require the translation and localization of on-device software elements such as UI strings. CSOFT provides end-to-end translation and localization solutions for point-of-care IVD device software, such as UI string localization; localization, cosmetic, and functional testing; and resource file localization.
Learn more about our software localization solutions.
IVD eLearning Translation Solutions
As point-of-care (POC) IVD medical devices become more common, healthcare professionals need to be trained on how to properly use such devices, which is commonly done through e-Learning. In addition, as IVD markets shift overseas, companies that open IVD manufacturing operations in foreign markets must provide eLearning solutions to ensure that all production staff are properly trained on how to correctly produce IVD kits. CSOFT provides eLearning translation and localization solutions to maximize product reach and ensure safe product operation across multiple markets. Specifically, CSOFT offers video translation services such as multilingual video voiceover, subtitling and dubbing.
Learn more about our eLearning solutions.
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.
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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.