Medical & Diagnostics Devices

Software for Medical and Diagnostic Devices

We develop solutions that ensure your medical and diagnostic devices operate safely and reliably while meeting all industry requirements. The software we create enhances device functionality, ensures regulatory compliance, and helps build long-term trust in your product.

• Development of embedded software and firmware (IEC 62304, SiMD)
• Integration of usability and risk management (IEC 62366, ISO 14971)
• Development of dedicated software in C/C++, “bare metal,” Linux Yocto, and RTOS
• Software compliant with IoT, IoMT, DTx (Digital Therapeutics) standards, and cloud solutions

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Maximum performance through standards compliance

We design and develop equipment that meets rigorous standards, ensuring durability, efficiency, and reliability at the same time. From concept to production, we create devices with the goal of delivering top performance in real-world conditions.

• Full-Product Engineering services – Concept Design, 3D CAD modeling, and mechanical/electrical/optical design
• PCB and schematic design in compliance with IEC 60601
• FEM simulation, prototyping, and hardware configuration
• Testing in secure laboratories
• Documentation preparation

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Reliable and accurate hardware performance

We offer built-in testing solutions that ensure the performance, consistency, and safety of devices while minimizing the risk of failure. We make sure they are fully ready for use by patients.

• Verification of compliance with standards (ISO 13485, IEC 62304, IEC 60601, IEC 62366)
• Integration with Quality Management Systems (QMS) and documentation
• Vulnerability, threat, and cybersecurity analysis
• Test automation
• Comprehensive quality testing (system, penetration, modular, integration, unit) – 100% code coverage in unit tests
• HIL testing (simulators, emulators, middleware)

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Cybersecurity of Medical Software and Devices

We offer comprehensive protection of cloud, data, and infrastructure, as well as monitoring services. We provide services in the field of security and compliance with medical industry standards (Medical Compliance) – for both SiMD and SaMD. We are certified according to ISO 13485.

• Implementation and maintenance of compliance standards with GDPR, ISO, NIS2
• Cybersecurity for medical devices (SiMD/SaMD)
• Ensuring compliance with requirements (MDR 2017/745, IVDR 2017/746, FDA 510(k), ISO 13485, ISO 14971, IEC 62304)
• Consulting in risk management (ISO 14971) and usability engineering (IEC 62366)
• Support in documentation and QMS, Design Control processes
• Ensuring compliance in sales, support, and documentation audits

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AI for drug development, R&D, and simulation

We use advanced artificial intelligence and bioinformatics to analyze complex biological data. Our solutions enable faster, data-driven research decisions, supporting drug discovery, therapy development, and personalized medicine.

• Data Science & Data Engineering
• Generative AI (LLM, RAG), Medical Text Processing (NLP)
• Image recognition and computer vision
• Support for research into drug discovery and therapy
• AI tools

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From concept to compliant product launch 

Sii delivers end-to-end product engineering services for medical and diagnostic companies that need one partner across design, hardware, embedded, software, cybersecurity, testing, and compliance. Our multidisciplinary team supports the full product lifecycle – from concept and prototype to validation, manufacturing handoff, and post-launch support – helping you reduce handoff risks, keep documentation aligned, and bring regulated products to market faster. 

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