What are In-Vitro Diagnostic Devices?
In-vitro diagnostic medical devices (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 Translation 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.
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.
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.
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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 medical device translation solutions. 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, terminology management, and in-country review (ICR) 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 process.