In vitro diagnostic medical devices (IVDs) are a unique classification of medical product that is extremely prevalent in the detection and treatment of medical conditions worldwide, making IVD translations a key need enabling medical device manufacturers to reach clinical settings worldwide. As well as needing to submit a variety of important documentation to meet regulatory standards and safety guidelines, translations for IVDs and medical devices that make use of in vitro diagnostics help ensure safe use in real clinical practice.
In greater detail, in vitro diagnostic medical devices and in vitro diagnostic products are a type of medical device that analyzes blood, tissue, and other specimens taken from patients to diagnose diseases and monitor health both in the clinic and at home. In addition to these applications in monitoring health, IVDs are also found in precision medicine, where they are used to identify patients who may be good candidates to receive new therapies or treatments. Common examples of IVDs that frequently need translation include:
- High-Throughput/Next-Generation Sequencing Tests
- Pregnancy Tests (e., hCG Tests)
- Clinical Chemistry Analyzers
- Urine Test Strips
- Blood Glucose Monitoring/Self-Testing
- HIV Blood Diagnostics
- Enzyme-Linked Immunosorbent Assay (ELISA) Kits
- SARS-CoV-2 and COVID-19 Tests
Localizing IVDs to Meet Rapidly Rising Demand Worldwide
The rising number of high-healthcare-utilizing elderly patients is predicted to cause the IVD and broader medical device market to shift from North America to overseas markets like Asia and South America in the coming years. With this shift, the need to provide high-quality and accurate IVD translations is vital for gaining regulatory compliance to sell IVD products in foreign markets. Regulation specific to IVDs can be difficult to navigate without the help of a certified and experienced language service provider. With a global network of subject matter experts and over 10,000 in-country native linguists, CSOFT Health Sciences offers highly accurate and timely in vitro diagnostic medical device translations for IVD manufacturers, such as instructions for use (IFU), package inserts, IVD software, and e-Learning videos in 250+ languages.
Comprehensive Medical Device Translation Solutions
Medical device translations help ensure regulatory approval and effective patient communication for medical device companies launching devices across languages. International regulatory bodies demand that IVDs and other types of medical devices are clearly labelled to guarantee patient safety and proper use. When IVDs and medical devices 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, IVDs and medical device 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 and potentially fatal delays in patient care.
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Multilingual IVD Device Clinical Trial Translations
Today, a growing number of clinical trials are conducted globally, with close to 90 percent of new drugs approved in 2021 undergoing trials and testing outside of their primary markets. As the demand for IVDs and other medical devices shifts overseas, accurately translated and culturally appropriate clinical trial documentation and patient recruitment material is vital for successful clinical trials, particularly when conducted on a flexible basis and with agile trial designs. From contract research organizations (CROs) and sponsors to institutional review boards and clinics, CSOFT Health Science’s medical translators have the linguistic and regulatory expertise and qualifications to help IVD device companies achieve international compliance through highly accurate clinical trial translations. CSOFT translates all types of IVD device clinical trial documentation, from clinical study protocol and informed consent forms to clinical study reports and pharmacovigilance reports (AEs/ARs/SAEs/SARs/SUSARs).
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IVD eLearning Translation Solutions
As POC IVDs and medical devices become more common, healthcare professionals, including physicians and nurses, need to be trained on how to properly use such devices, which is commonly done through eLearning. 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 Health Sciences leverages a global team of over 10,000 subject matter experts and in-country linguists when providing eLearning medical translation and localization solutions to maximize product reach and ensure safe product operation across multiple markets. Additionally, CSOFT offers life science video translation services such as multilingual video voiceover, subtitling, and dubbing.
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CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. Every step of the way, CSOFT has you covered.
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With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
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