Reliable & safe device functionality

We develop software solutions that ensure your medical and diagnostic devices operate safely and reliably while meeting all industry regulations. The software we develop enhances device functionality, maintains compliance, and builds long-term trust in your product’s performance.

• Embedded firmware and software development (IEC 62304, SiMD)
• Integration of usability and risk management (IEC 62366, ISO 14971)
• Custom development including C/C++, bare metal, Linux Yocto, and RTOS

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Top performance with compliant hardware

We design and develop hardware that meets all compliance standards while delivering durability, efficiency, and reliability. From initial design to final production, our solutions ensure your devices are built for the best performance in real-world conditions.

• 3D CAD modeling and mechanical design
• PCB and schematic design following IEC 60601
• Simulation, prototyping, and hardware setup
• Comprehensive testing with secure lab facilities

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Guarantee the reliability and accuracy of your devices.

We provide embedded testing services that thoroughly assess your devices to guarantee accurate and consistent performance. Our approach minimizes the risk of failure, ensuring your devices are safe and fully prepared for patient use.

• Compliance testing (ISO 13485, IEC 62304, IEC 60601)
• Detailed traceability and QMS integration
• Vulnerability and threat analysis
• High automation in testing with 100% code coverage

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Threat defense for consistent device reliability

We deliver security solutions that safeguard your devices from cyber threats and other risks, ensuring they remain secure, perform reliably, and fully comply with industry standards.

• Implementation of GDPR, ISO standards, and compliance norms
• Cybersecurity solutions specific to medical devices
• Consulting on regulatory affairs and risk management
• Ongoing support and document management for compliance

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Integrated & protected digital health systems

We connect and secure IoMT and digital health systems, enabling seamless communication between devices. The solutions we delievr protect sensitive data which, in turn, leads to improved patient outcomes.

• Internet of Medical Things and interoperability
• Digital therapeutics and cloud
• Mobile & Web Software as a Medical Device
• Cybersecurity modeling and planning

AI tools for improved diagnostic accuracy

Our AI-driven tools and data analytics enhance diagnostic accuracy and enable tailored treatments, helping your devices deliver more effective patient care and improving overall outcomes.

• Data Analytics & Management, Collection, and Visualization
• Drug Discovery and Therapy Support
• AI, Machine Learning, Deep Learning, and NLP
• Image Recognition, Computer Vision, and Data Science
• Real-World Data, Evidence, and Decision Optimization
• Recommendation Systems and Predictive Analytics