Software as a Medical Device (SaMD) Solutions

Delivering intelligent, compliant, and connected SaMD solutions to enhance patient care, streamline workflows, and drive innovation.

Transforming Healthcare with Intelligent SaMD Solutions

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’re shaping the future of digital healthcare.

What We Offer

Comprehensive SaMD Development

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.

Seamless Medical Device Connectivity

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.
 

Regulatory Compliance and Security

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).
 

Cross-Platform Development and Optimization

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.

Engineering healthcare impact: How we help
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.

Wearable Application for Health Monitoring

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.

Insulin Pump Controller for Diabetes Management

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.

ePRO Solution for Cancer Patients

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.

Smartwatch SaMD for Biometric Monitoring

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.

FAQs

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.

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.

SaMD applications integrate with a wide range of devices, including wearable health monitors, implantable devices, insulin pumps, and smartwatches. GlobalLogic’s expertise in BLE, WiFi, and 4G/5G connectivity ensures secure and efficient data exchange between medical devices, mobile platforms, and the cloud.

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.

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.

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Meet Our Experts

Julieta
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The opportunities for growth and learning are endless, it is a very good place to pursue a career! Also, people are VERY cool, if you work at GL you will end up making friends.

Julieta, Marketing Specialist

 

Priscilla
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Day by day you learn something new, the possibility of working with other cultures, countries, different ways of thinking, makes you challenge yourself all the time and is nourished by new possibilities.

Priscilla, L&D Manager

 

Vikas
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Working with GlobalLogic has given me the opportunity to contribute to make a lasting impact in the life of many through our work across Industries. At GlobalLogic, I continue to pursue my passion of working on futuristic technology. I started back in 2009 and grew rapidly. Today, I am focused on Thought Leadership, Digital Acceleration, and Future Ready Talent for the next level of growth. Future is already here at GlobalLogic!

Vikas, AVP, Technology

 

Ibrahim
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As an Atlassian Consultant, I help a wide variety of companies realize their full potential by enabling strong collaboration between their teams. With the help of Jira or Confluence, for example, cooperation and knowledge sharing can be digitized and simplified. At GlobalLogic, I have the support of a strong team for this and the freedom to continuously educate myself.

Ibrahim, Atlassian Consultant

 

Prabhu
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With 26+ years of experience, I have successfully architected, managed & delivered projects across various industry verticals and led teams of all sizes. I have also driven the strategic IT direction of client organizations, leveraging emerging technologies and best practices that exhibit the potential for improving execution, efficiency and effectiveness. I am passionate about re-visioning complex challenges, motivating teams to execute successfully through insight and taking big ideas forward.

Prabhu, Principal Architect, Technology

 

Per-Anders
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As a GlobalLogic employee, I feel it’s natural to always strive for meet or exceed the client expectations. I have always appreciated GlobalLogic Sweden’s flat organization enabling casual and personal relations with all members of the GlobalLogic team. I also enjoy the constant opportunities to every day develop new knowledge in todays and future technologies.

Per-Anders, System Engineer

 

Per-Anders
quote

As a GlobalLogic employee, I feel it’s natural to always strive for meet or exceed the client expectations. I have always appreciated GlobalLogic Sweden’s flat organization enabling casual and personal relations with all members of the GlobalLogic team. I also enjoy the constant opportunities to every day develop new knowledge in todays and future technologies.

Per-Anders, System Engineer

 

Sourav
quote

It has always been very easy to communicate with everyone at the company when I have any issues or questions and the resolutions are really fast too. This was my first time coming and working in Sweden and everything was really smooth. Everyone is really friendly and helpful. I also got into a good project and got a lot of exposure working in it. I learnt a lot and have been growing continuously since then.

Sourav, Senior Software Engineer

 

Sourav
quote

It has always been very easy to communicate with everyone at the company when I have any issues or questions and the resolutions are really fast too. This was my first time coming and working in Sweden and everything was really smooth. Everyone is really friendly and helpful. I also got into a good project and got a lot of exposure working in it. I learnt a lot and have been growing continuously since then.

Sourav, Senior Software Engineer

 

Piotr
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Currently, he works for the biggest automotive player in Europe. He is part of the team responsible for creating Head-Up Display for upcoming Mercedes in 2022. Piotr is responsible for features development and various testing, including functional safety. He strongly believes that a positive atmosphere at the workplace has great importance and contributes to productive and pleasant work life.

Piotr, Software Engineer

 

Piotr
quote

Currently, he works for the biggest automotive player in Europe. He is part of the team responsible for creating Head-Up Display for upcoming Mercedes in 2022. Piotr is responsible for features development and various testing, including functional safety. He strongly believes that a positive atmosphere at the workplace has great importance and contributes to productive and pleasant work life.

Piotr, Software Engineer

 

Konrad
quote

He works in the Gateway Diagnostics team of the ICAS1 project for our customer - one of the leading Tier1 Automotive suppliers. He graduated from West Pomeranian University with an Electronics and Telecommunications degree. Truly passionate about programming, Embedded Systems, and everything related to new technologies.

Konrad, Software Developer

 

Paweł
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He is working in Big Data project for a major international pharmaceutical company, leading and supporting multiple Scrum teams distributed over 3 countries and 2 continents. His responsibilities are focused on handling relations and information exchange between the team and stakeholders in a dynamically changing environment of agile software development.

Paweł, ​Scrum Master

 

Jurata
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She is a Requirements Engineer in the automotive field and a Leader of Requirements Engineers in the Polish part of the project (17 people across 3 locations). She is also responsible for software requirements in the system, currently focused on diagnostics. Jurata actively participates in international conferences and events, e.g. Impact mobility rEVolution or Women in Technology Poland birthday event.

Jurata, Business Analyst

 

Paweł​
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His tasks involve creating automated tests, as well as testing applications and firmware. Mentoring skills are the factor that makes him stand out: he supports new employees, juniors, and regular testers. Paweł is also an enthusiast of Lego Mindstorms and Lego Technic, participating in Lego SUMO competitions.

Paweł​, Senior Test Engineer

 

Damian
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Damian works for the project for Continental - the world’s leading automotive manufacturing company. In his everyday work, he is responsible for software development. Pushing the boundaries is his passion.

Damian, Software Engineer

 

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