Camgenium Launches Soft Silicon: Accelerating Secure & Compliant, Medical IoT Connectivity
Camgenium’s Soft Silicon platform empowers rapid, secure, and compliant connected medical device innovation—delivering advanced firmware, cloud integration, and lifecycle management for Nordic Semiconductor devices.
Cambridge, UK – June 27, 2025 – Camgenium, a leader in medical device software development and secure cloud infrastructure, is proud to announce the release of its next-generation Soft Silicon firmware for Nordic Semiconductor devices. This comprehensive solution is engineered to streamline the development, deployment, and management of connected medical devices — enabling innovators to move from prototype to production with unprecedented speed and confidence. Camgenium offers the non-regulatory compliant version of Soft Silicon firmware free of charge with a range of low cost cloud services with differing levels of SLA, for prototyping and non-medical applications.
A New Standard for Medical IoT Connectivity
Soft Silicon provides a feature-rich, IEC 62304-ready communications stack out of the box, including BLE mesh networking, ultra-low power operation, secure over-the-air updates, BLE-to-Wi-Fi 6 bridging, and robust encrypted storage. With support for real-time synchronization, external FLASH, advanced instrument interfaces, and NFC Smart Card ISO 7816-4, Soft Silicon ensures future-proof connectivity and security for healthcare applications.
MedTech Compliance and Security
Camgenium’s cloud infrastructure Soft Silicon platform is certified to HIPAA, SoC1, SoC2, ISO 27001, and NHS standards, with the company holding ISO 13485 certification by BSI. This guarantees medical device developers a trusted, professional deployment environment—reducing regulatory complexity and accelerating time to market.
Flexible Access for Innovators
To support rapid development, Camgenium offers the Soft Silicon firmware feature set in a non-regulatory compliant version free of charge for prototyping and non-medical applications. The free of charge version is provided without IEC 62304 documentation for prototyping. Medical device developers can build and test with no upfront costs, upgrading to the fully compliant, documented, and medically networked version only when ready for regulatory submission. The full IEC 62304 documentation with validation evidence is available for purchase once the device is ready to be submitted to the notified body.
Trusted Experience, Proven Results
Camgenium’s technology powers national healthcare infrastructure and frontline medical applications worldwide. Its solutions are designed to help customers reduce development time, minimise risk, and achieve compliance with confidence. Camgenium has already successfully deployed Soft Silicon technology in a new medical device prototype for pacing technology, Pace-Protect, in collaboration with its partner, Cardiac Tech.
