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Software as a Medical Device (SaMD) Translations

We offer high-quality software as a medical device (SaMD) translations and localization solutions in 250+ languages to reach new markets and patients on a global scale

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Home 9 Software as a Medical Device (SaMD) Translations

In the medical field, software has a growing place in accelerating our ability to discover, manage, and treat all types of conditions, which makes Software as a Medical Device (SaMD) translations essential for integrating this technology into global medical markets. By U.S. Food and Drug Administration (FDA) standards, SaMD is any software that carries out medical functions without actual hardware. SaMD plays a specific role within medical devices and healthcare operations, including the software used to control infusion pump motors and the software that enables medical communications, like video calling, scheduling appointments, and digital patient registration. More broadly, the applications of SaMD platforms include diagnosing and screening, monitoring and alerting, disease and condition management, and digital therapeutics. Since SaMD is relatively new, finding its place in the digital health space has prompted regulators, including the FDA, EMA, and International Medical Device Regulators Forum (IMDRF), to actively develop guidance and framework to help promote safe innovation and uphold patient protections.
As SaMD platforms continue to advance, the global integration of this technology demands that the materials and content necessary for driving this growth be available in any language and tailored to the needs of any market. To help companies safely and efficiently bring this technology overseas, CSOFT Health Sciences provides expert localization solutions and software as a medical device (SaMD) translations in over 250 languages.

In addition to SaMD translations, our global network of linguists and subject matter experts offer a full range of medical translation and localization solutions for the medical device industry, including:

Medical Software Localization

Medical software plays a broad function in healthcare systems today, from enabling doctors to view electronic health records (EHRs) to serving as a diagnostic tool like SaMD. As a multi-billion-dollar industry with rapid growth in recent years, medical software is the backbone of hospitals, outpatient clinics, and urgent care facilities. It enables medical workers to connect with patients and deliver high-quality care. To ensure that medical workers, patients, and manufacturers of all backgrounds and languages can operate and develop medical software to standards, it is necessary that the software be localized and the linguistic elements be translated to meet local needs. With a network of linguists and subject matter experts in medical software, CSOFT Health Sciences provides medical software localization, including UX/UI strings, linguistic, function, and cosmetic testing, and DevOps continuous translation.

In addition to software localization, we offer translations of medical software’s linguistic components, including patient portal translations.

Learn more about our software localization.

Medical Device Translation and Localization Solutions

When bringing medical devices to international markets, professional software localization for medical devices is critical in ensuring their global success across the product life cycle and for the safety and efficacy of the therapy for patients. Medical device software translations are similar to the standard localization process: the software user interface (UI) strings are extracted and held in an external resource before being translated into the desired languages and then recompiled back into the source application. With this, however, linguistic validation, quality assurance, and cosmetic and functional testing are crucial for the overall success of medical device software localization and translation.

CSOFT Health Sciences provides expert medical device software translation services. With a network of over 10,000 linguists worldwide who work with software engineers and project managers, we ensure the highest-quality translation for software for the best ROI.

Learn more about our medical device translation.

Mobile Medical App Translations

In digital medical solutions, mobile medical app translations have become an innovative tool for collecting valuable health data and monitoring, diagnosing, and discovering medical conditions globally. On the end user’s side, mobile medical apps enable patients and patient proxies to schedule appointments, access health records, and monitor vital signs or glucose levels. On the side of a provider, these apps have advanced to the level at which doctors can prescribe medication and diagnose conditions without ever interacting with the patient in person by improving accessibility with remote visits. As the widespread deployment of this technology reaches new markets and end users globally, translations of the linguistic content and regulations in place to develop medical apps are essential for growth. In addition to translations for mobile medical apps, we offer translations for the regulations that direct the development, oversight, and sale of these medical apps in global markets, including CE marking translations and MDR translations for EU markets.

Learn more about our mobile medical app translations.

A.I. Translations

Clinical Decision Support Translations

Clinical decision-support translations enable clinicians and other healthcare workers to provide the best possible care for patients worldwide. Clinical decision support, sometimes called CDS, are tools used to improve point-of-care decision-making, such as medication alerts, risk scores for disease or condition, and computer-aided detection or diagnosis (CADe/CADx). With the growth of AI and machine learning applications in healthcare, including generative AI like ChatGPT, these systems are even more important to provide up-to-date and efficient care for patients. Importantly, some clinical decision support software may be regulated as medical devices under guidance from the U.S. FDA and other regulatory bodies. Even for Non-Device CDS, accurate medical translation of materials from regulatory experts and software localization by experienced engineers is crucial to ensure the best care.

Learn more about our clinical decision support 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.

Learn more about our quality assurance process.

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.


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