In vitro diagnostic medical devices (IVDs) are a unique class of medical products with a market size of over 90 billion USD. They are crucial in detecting and treating medical conditions worldwide, making IVD translations essential in enabling medical device manufacturers to reach clinical settings globally while adhering to regulatory standards and safety guidelines. Translations are pivotal in ensuring the safe use of IVDs and other diagnostic medical devices in real clinical contexts.
VDs, including related products, analyze patient specimens like blood and tissue for disease diagnosis and health monitoring, spanning diverse settings from clinics to homes. Beyond health monitoring, IVDs significantly contribute to precision medicine by identifying suitable candidates for new therapies or treatments. Examples of IVDs that frequently require 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, providing 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 challenging 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 medical devices be clearly labeled 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.
Learn more about our full range of medical device translation solutions .
Multilingual IVD Device Clinical Trial Translations
Today, a growing number of clinical trials are conducted globally, with nearly 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 are vital for successful clinical trials, particularly when conducted flexibly 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).
Learn more about our clinical trial translations.
Point of Care IVD Software Translation and Localization
Point-of-care IVDs allow for remote testing at patient care sites such as patient homes, enabling healthcare professionals to receive real-time test results and improve disease monitoring. To market such in vitro diagnostic point of care (POC) testing devices internationally, POC IVDs require medical translation and localization of on-device software elements such as UI strings. Comprehensive localization of software interfaces is crucial to ensure that point-of-care IVD devices cater to a global audience. This includes direct translation of user interface components and cultural adaptation to meet local healthcare standards and practices. Our service extends to localizing all software elements, guaranteeing that UI and user instructions are clear, accessible, and legally compliant for users in various international markets.
Learn more about our software localization solutions.
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 produce IVD kits correctly. Additionally, CSOFT offers life science video translation services such as multilingual video voiceover, subtitling, and dubbing.
Learn more about our e–Learning translations.
Quality Assurance
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 at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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Data Security
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 the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.