What are In-Vitro Diagnostic Devices?
In-vitro diagnostic devices (IVD) are a type of medical device that analyze blood, issue, and other specimens taken from patients to diagnose diseases, monitor health. In addition to monitoring health, IVD 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 IVDs include:
- Next-generation Sequencing Tests
- Pregnancy Tests
- Clinical Chemistry Analyzers
- Urine Test Strips
- Blood Glucose Self-testing
- HIV Blood Diagnostic
- Enzyme-Linked Immuno Sorbent Assay (ELISA) Kits
The rising number of elderly patients is predicted to cause the IVD market to shift from North America to overseas. With this shift, the need to provide high-quality and accurately translated IVD components such as instructions for use (IFU), package inserts and labels are vital for gaining regulatory compliance to sell IVDs in foreign markets is crucial for the medical device’s success. With a large network of subject matter experts and a global network of 10,000 in-country native linguists, CSOFT can offer highly-accurate and timely multilingual translation and localization solutions for IVD such as IVD labelling, on-device software, and eLearning videos in 250+ languages.
In-Vitro Diagnostic Device Translation Solutions
Multiple international regulatory bodies demand that IVDs are clearly labelled to guarantee patient safety and proper use. When IVDs 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 10,000 linguists can provide IVD companies with highly-accurate and timely IVD label translation solutions in 250+ languages.
Learn more about our medical device label translation solutions
Point of Care IVD Software Translation and Localization
Point-of-care IVD medical device allows for remote testing at patient care sites such as patient homes, enabling healthcare professionals to receive real-time test results. To market such devices internationally, point-of-care devices 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
As point-of-care (POC) IVD medical devices become more common, healthcare professionals need to be trained on how to properly use such devices. In addition, as IVD markets shift overseas, companies that open IVD manufacturing operations in foreign markets must 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.
We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified 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 our data security.
High-quality translation is extremely important in IVDs, which are highly complex devices that require precise instructions to operate effectively. Inaccurate translation along the way can not only result in wasted time, money, and effort, but also negatively affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation solutions for IVDs. In order to do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through linguistic validation, back translation, and terminology management, we have the tools and team to help you meet the submission demands of regulatory bodies such as the FDA, EMA, and NMPA.
Read more about our quality assurance.