Why are Language Services for Software as a Medical Device Important?
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 the need for actual hardware. SaMD plays a specific role within medical devices and healthcare operations, including as 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, 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 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 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 Device Translation and Localization Solutions
When bringing medical devices to international markets, professional software localization for medical devices is critical in ensuring its global success across the product life cycle, as well as 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 original source application. With this, however, linguistic validation, quality assurance, and testing for functionality as well as cosmetically are crucial for the overall success in medical device software localization and translation.
CSOFT Health Sciences provides expert medical device software translation services. With a network of over 10,000 linguists located all over the world, 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 devices translation.
Mobile Medical App Translations
In the space of digital medical solutions, mobile medical app translations 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 patients and patient proxies to schedule appointments, access health records, and even monitor vital signs or glucose level. 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. With proven experience in medical software localization and a global network of over 10,000 subject matter expert 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.
Clinical Decision Support Translations
Clinical decision support translations enable clinicians and other healthcare workers to provide the best possible care for patients around the world. 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 only the best care. CSOFT Health Sciences leverages a global team of over 10,000 linguists, subject matter experts, and software engineers to provide clinical decision support translations for healthcare providers across languages.
Learn more about our clinical decision support translations.
质量保证
通过我们基于云的创新技术，CSOFT华也生命科学提供了一个在线翻译管理生态系统，系统中心位置实时利用翻译记忆以及术语管理。
高质量的翻译和本地化业务对政府机构极为重要 - 不准确的翻译不仅会导致时间、成本和精力的浪费，而且还会影响患者和消费者的生活。这就是为什么CSOFT华也生命科学致力于确保最高质量的翻译服务。为此，我们聘请至少有7年经验的本土语言学家，并且不断拓展我们的多领域主题专家网络。此外，我们通过语言验证、回译和术语管理不断完善本地化最佳实践，帮助政府机构、非政府组织、公共部门和国际组织接触不同文化背景的社区。为了确保高质量的技术翻译解决方案，CSOFT华也生命科学的专业性得到了ISO 17100:2015、ISO 9001:2015和ISO 13485:2016认证的质量管理体系的支持。同时，我们的操作流程符合ISO 27001的最佳实践，确保我们的定制化解决方案符合全球监管要求。
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数据安全
拥有20多年医学翻译经验的CSOFT华也生命科学深谙数据安全对我们客户的重要性，当涉及到保密问题时，我们从不会掉以轻心。我们拥有完善的文档和完全可追溯的信息安全政策、检查表和质量记录。同时，我们的操作流程与 ISO 27001 提供的最佳实践方式保持一致，保障客户信息的安全。
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