Software Engineering
Reduce risk and accelerate medical software development schedules with our team of over 50 dedicated software engineers with broad and deep expertise in full-stack software development.
Sunrise Labs specializes in architecting, implementing, and testing Class II and Class III medical devices, leveraging a risk-based approach. Our modified Agile methodology provides visibility throughout the project. We provide complete lifecycle solutions to meet your needs for functionality, maintainability, and compliance.
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- IEC-62304 based SDLC process
- Full tech stack software development
- Embedded Development
- Application Layer Development
- GUI prototyping and development (Web, Mobile, and Embedded)
- Local and Cloud Data storage and security
- Cloud and Server Architecture
- Wired and wireless communications
- Network protocols (Ethernet, TCP/IP, UDP, MQTT…)
- Risk Management per ISO 14971
- Software Safety Class A, B, C
- V-Model Development
- Cybersecurity; threat modeling, FMEA, and mitigation, threat monitoring and mitigation for full medical device life-cycle
- Machine learning (ML), and Artificial Intelligence (AI)
- Advanced algorithm development
- Unit Test Development and Execution
- DevOps tools and frameworks
- CI/CD and Automated Testing Strategies
- Medical device software development, including software design and project management
Meet our Directors of Software
Christine Nason
Christine is a hands-on software manager/principal engineer with over 20 years of experience developing software and leading teams for embedded systems on medical devices, lab automation applications, and green technologies.
Jeffrey Reaume
Jeffrey has over 30 years of experience in software development, predominantly in FDA class II and class III medical devices. Jeffrey’s experience includes leading technical teams on complex electro-mechanical and energy delivery systems, establishing software processes, and executing validation and verification.
Enhancing Focus Through EEG Technology
Sunrise Labs collaborated with a client to develop a head-worn EEG monitoring device that uses brain wave data to provide real-time feedback through a tablet-based game. The project involved designing reliable electronics, firmware, and BLE connectivity, ensuring a robust product suitable for home use. The medical device met all product requirements and transitioned seamlessly to volume production.
Advancing Respiratory Care with Modern Software Solutions
Sunrise Labs partnered with a mission-driven startup to modernize a decades-old respiratory therapy device, transforming it into a cost-effective, Bluetooth-enabled solution. By integrating a user-friendly mobile app, the system now empowers individuals to monitor and improve their respiratory health through guided breathing exercises.
Strength through strategy
and transformation
Our agile medical device project management is backed by years of experience across industry niches, revolutionary technologies, and organizations of all sizes.
Sunrise Labs doesn’t stop at the design stage. We are here to support your complete medical product life cycle.
Explore Deeper Insights on Medical Software Engineering
Check out our in-depth webinar recordings and articles to gain a better understanding of our approach to software engineering for medical device product development.
Discover Our Full Range of Medical Product Expertise
At Sunrise Labs, we specialize in Software Engineering. But that’s just one part of the story. From concept development to clinical readiness, our expertise spans every stage of medical device development and life sciences innovation.