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 US Food and Drug Administration (FDA) standards, SaMD is any software that carries out medical functions without the need of actual hardware. As a relatively new field within healthcare, SaMD plays a specific role, such as the software used to control infusion pump motors or 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 localization solutions for the medical device industry, including:

Learn more about our medical device translations.

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, and enables medical workers to connect with patients and deliver high-quality care. To ensure that medical workers, patients, and manufactures of all backgrounds and languages are able to operate and develop medical software to standards, it is necessary that the software be localized, and the linguistic elements be translated. With a network of linguists and subject matter experts in medical software, CSOFT Health Sciences provides medical software localization including for UX/UI strings, linguistic, function, and cosmetic testing, and DevOps continuous translation.

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

Learn more about our software localization.

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, and enables medical workers to connect with patients and deliver high-quality care. To ensure that medical workers, patients, and manufactures of all backgrounds and languages are able to operate and develop medical software to standards, it is necessary that the software be localized, and the linguistic elements be translated. With a network of linguists and subject matter experts in medical software, CSOFT Health Sciences provides medical software localization including for UX/UI strings, linguistic, function, and cosmetic testing, and DevOps continuous translation.

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

Learn more about our software localization.

Mobile Medical App Translations

In the space of digital medical solutions, mobile medical apps have become an innovative tool for collecting valuable health data and monitoring, diagnosing, and discovering medical conditions on a global scale. On the side of the end user, mobile medical apps enable someone to schedule appointments, access health records, and even monitor vital signs or glucose level. Conversely, 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. As the widespread deployment of this technology reach new markets and end users globally, translations of the linguistic content and regulations in place to develop medical apps are essential for growth. With proven experience in medical software localization and a global network of translators, CSOFT Health Sciences provides mobile medical app translations to help facilitate growth and reach new markets.

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.

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Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. 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 and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

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