{"id":101935,"date":"2024-12-24T08:42:33","date_gmt":"2024-12-24T08:42:33","guid":{"rendered":"https:\/\/www.globallogic.com\/latam\/?post_type=industries&p=101935"},"modified":"2025-01-20T10:34:16","modified_gmt":"2025-01-20T10:34:16","slug":"software-as-a-medical-device-samd","status":"publish","type":"industries","link":"https:\/\/www.globallogic.com\/latam\/industries\/healthcare-and-life-sciences\/software-as-a-medical-device-samd\/","title":{"rendered":"Software as a Medical Device (SaMD)"},"content":{"rendered":"\n
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Transforming healthcare with intelligent SaMD solutions<\/h2>\n\n\n\n
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Software as a Medical Device (SaMD) is transforming healthcare by delivering smarter, more connected solutions for diagnosis, treatment, and patient monitoring. GlobalLogic partners with leading MedTech and healthcare innovators to design and engineer compliant, secure, and intuitive SaMD applications. With our expertise spanning mobile platforms, device connectivity, and regulatory requirements, we help organizations enhance patient outcomes, streamline operations, and reduce costs. Together, we\u2019re shaping the future of digital healthcare.<\/p>\n<\/div><\/div>\n\n\n\n

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What we offer<\/h2>\n\n\n\n
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Comprehensive SaMD Development<\/strong><\/p>\n\n\n\n

GlobalLogic specializes in creating Software as a Medical Device (SaMD) solutions that leverage patient-related data for diagnostics, treatment, and prevention. From Class I to Class III devices, we design high-performance software that meets strict regulatory standards while delivering intuitive and secure user experiences.<\/p>\n<\/blockquote>\n\n\n\n

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Seamless Medical Device Connectivity<\/strong>

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Our expertise in BLE, WiFi, and 4G\/5G technologies ensures seamless connectivity between medical devices and mobile or cloud platforms. This capability optimizes data flow, reduces communication costs, and enhances device usability for both patients and providers.<\/p>\n<\/blockquote>\n\n\n\n

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Regulatory Compliance and Security<\/strong>

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We adhere to international standards like ISO 13485, ISO 14971, and IEC 62304 to ensure SaMD solutions are compliant, secure, and ready for global markets. Our extensive QMS experience helps streamline regulatory submissions and maintain a compliant Design History File (DHF).<\/p>\n<\/blockquote>\n\n\n\n

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Cross-Platform Development and Optimization<\/strong>

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GlobalLogic delivers SaMD solutions optimized for iOS, Android, and cross-platform frameworks, enabling BYOD deployment or dedicated device management. Our expertise ensures seamless integration, cost-effective operations, and an engaging user experience across all platforms.<\/p>\n<\/blockquote>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\r\n

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Engineering healthcare impact<\/div>\r\n

How we help<\/h2>\r\n

GlobalLogic collaborates with leading MedTech and healthcare innovators to deliver cutting-edge SaMD solutions that enhance patient care, streamline operations, and ensure regulatory compliance. Our real-world expertise drives meaningful impact across a range of use cases, from improving chronic disease management to enabling advanced medical device connectivity.\r\n<\/p>\r\n <\/div>\r\n <\/div>\r\n \r\n

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Wearable Application for Health Monitoring<\/h4>\n

GlobalLogic developed a flexible, extensible SaMD framework for a multinational medical devices company, enabling the rapid deployment of wearable and mobile applications. This solution allows the client to collect and adjust biometric data seamlessly, saving time and resources while enhancing the patient experience.<\/span><\/p>\n <\/div>\r\n

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Insulin Pump Controller for Diabetes Management<\/h4>\n

Partnering with a diabetes startup, GlobalLogic engineered a mobile controller application that integrates seamlessly with insulin pumps. By leveraging our QMS expertise, we ensured regulatory compliance while empowering patients with precise insulin management tools and real-time insights.<\/span><\/p>\n <\/div>\r\n

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ePRO Solution for Cancer Patients<\/h4>\n

GlobalLogic provided full-cycle development of a SaMD ePRO solution for a Swiss-based startup. Our team delivered an intuitive UI\/UX design for web and mobile applications, integrated back-end services, and supported MDD certification in Switzerland and the EU, improving usability for patients and streamlining clinical processes.<\/span><\/p>\n <\/div>\r\n

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Smartwatch SaMD for Biometric Monitoring<\/h4>\n

GlobalLogic partnered with a global medical device manufacturer to create a smartwatch-based SaMD application. By leveraging popular mobile platforms, we enhanced patient engagement, enabled biometric data collection, and ensured seamless cloud integration for advanced analytics, improving therapy management and study outcomes.<\/span><\/p>\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/section>\r\n\n\n

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Featured insights <\/h2>\n <\/div>\n <\/div>\n
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Explore fresh thinking from GlobalLogic\u2019s strategists and engineers.<\/p>\n See all<\/a>\n <\/div>\n <\/div>\n\n

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Blogs<\/div>
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\n\n Sergio Fiorillo<\/span><\/a>\n <\/div>\n\n \n 18 junio 2024 <\/span>\n <\/div>\n

\n \n Colaboraciones Offshore: Claves para una Transformaci\u00f3n Digital Exitosa <\/a>\n <\/h3>\n
\n Cross-Industry<\/span> <\/div>\n <\/div>\n \n \"Colaboraciones <\/a>\n <\/div>\n <\/div>\n
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Blogs<\/div>
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\n\n Priscila Santoro<\/span><\/a>\n <\/div>\n\n \n 18 mayo 2023 <\/span>\n <\/div>\n

\n \n Superpoder 2.0: Domin\u00e1 el futuro de tu carrera aprendiendo a aprender <\/a>\n <\/h3>\n

Por Priscila Santoro, Learning & Development LatAm Manager   Upskilling,…<\/p>

\n AI Governance<\/span>MLOps<\/span>Cross-Industry<\/span> <\/div>\n <\/div>\n \n \"Superpoder <\/a>\n <\/div>\n <\/div>\n
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White Papers<\/div>
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\n\n Pablo Javier Ruiz<\/span><\/a>\n <\/div>\n\n \n 14 marzo 2023 <\/span>\n <\/div>\n

\n \n Automatizando el criterio de contraste de color AA y AAA de WCAG <\/a>\n <\/h3>\n

Las pautas de accesibilidad al contenido web (WCAG \/ Web…<\/p>

\n Testing-as-a-Service<\/span>Cross-Industry<\/span> <\/div>\n <\/div>\n \n \"Automatizando <\/a>\n <\/div>\n <\/div>\n \n <\/div>\n
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FAQs<\/div>\r\n
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Your SaMD questions, answered<\/h2>\r\n <\/div>\r\n <\/div>\r\n
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  • \r\n
    What is Software as a Medical Device (SaMD)?<\/div><\/div>\r\n
    Software as a Medical Device (SaMD) is regulated software designed for medical purposes such as disease diagnosis, treatment, or patient monitoring. SaMD operates on general-purpose devices like smartphones or cloud platforms, delivering innovative healthcare capabilities such as patient monitoring, analytics, and personalized treatment.\r\n<\/div>\r\n <\/li>\r\n
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    How does GlobalLogic support SaMD development?<\/div><\/div>\r\n
    GlobalLogic offers end-to-end SaMD development services, including design, engineering, and comprehensive testing. We specialize in creating intuitive, secure software that integrates seamlessly with medical devices, adheres to global standards like ISO 13485 and IEC 62304, and enhances patient outcomes while ensuring compliance.\r\n<\/div>\r\n <\/li>\r\n
  • \r\n
    What types of devices can integrate with SaMD applications?<\/div><\/div>\r\n
    SaMD applications integrate with a wide range of devices, including wearable health monitors, implantable devices, insulin pumps, and smartwatches. GlobalLogic\u2019s expertise in BLE, WiFi, and 4G\/5G connectivity ensures secure and efficient data exchange between medical devices, mobile platforms, and the cloud.\r\n<\/div>\r\n <\/li>\r\n
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    How do SaMD applications benefit patients and providers?<\/div><\/div>\r\n
    SaMD improves patient care by enabling real-time monitoring, remote management, and personalized treatment. It empowers providers with actionable insights, streamlines clinical workflows, and reduces operational costs by leveraging connected systems and intuitive interfaces.\r\n<\/div>\r\n <\/li>\r\n
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    Can GlobalLogic ensure regulatory compliance for SaMD solutions?<\/div><\/div>\r\n
    Yes, GlobalLogic has extensive experience adhering to global medical device regulations. We understand and apply data privacy and cybersecurity regulations as well as industry standards like ISO 13485, ISO 14971, and IEC 62304 to ensure compliance throughout the software lifecycle. Our expertise includes developing compliant Design History Files (DHF) and supporting regulatory submissions.\r\n<\/div>\r\n <\/li>\r\n <\/ul>\r\n <\/div>\r\n <\/section>\r\n","protected":false},"author":97,"featured_media":101938,"parent":227,"menu_order":32,"template":"","work-with-us-category":[19],"class_list":["post-101935","industries","type-industries","status-publish","has-post-thumbnail","hentry","work-with-us-category-industries"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/industries\/101935","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/industries"}],"about":[{"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/types\/industries"}],"author":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/users\/97"}],"version-history":[{"count":1,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/industries\/101935\/revisions"}],"predecessor-version":[{"id":101940,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/industries\/101935\/revisions\/101940"}],"up":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/industries\/227"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/media\/101938"}],"wp:attachment":[{"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/media?parent=101935"}],"wp:term":[{"taxonomy":"work-with-us-category","embeddable":true,"href":"https:\/\/www.globallogic.com\/latam\/wp-json\/wp\/v2\/work-with-us-category?post=101935"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}