Foundation Core delivers IEC 62304:2006+AMD1:2015-compliant communications, logging, security, and safety monitoring as a drop-in SPI peripheral on the Nordic nRF5340 SoC. Your application talks to compliance over SPI.
Foundation Core presents as a standard SPI peripheral to the host application
Foundation Core packages the regulatory infrastructure that every connected medical device needs, including compliant communications, audit-grade logging, secure boot, encrypted firmware updates, and safety monitoring, into a single Nordic nRF5340 SoC.
The platform presents as a standard SPI peripheral. Your application processor talks to Foundation Core over SPI and inherits its compliance properties without the cost and complexity of building regulatory infrastructure from scratch.
Certified once. Reused many times.
Every capability an OEM needs to build a connected, compliant medical device, delivered as pre-certified infrastructure.
CryptoCell-312 hardware accelerator provides secure boot, encrypted firmware storage, and authenticated OTA updates. Key management via the nRF5340's KMU.
Comprehensive device logging with tamper-evident records, real-time clock management, and data buffering that preserves clinical observations during connectivity interruptions.
Transparent switching between BLE, Wi-Fi 6 (nRF7002), and cellular IoT (nRF9151) without changes to application code. BLE Mesh for ward-scale coverage.
The nRF5340's dual-core architecture provides hardware-enforced separation between the communications stack and safety monitor, supporting IEC 62304:2006+AMD1:2015 Class B and C requirements.
Bluetooth 5.3 with standard GATT profile services, providing a well-defined interface for companion mobile applications and gateway devices.
Exposes Foundation's compliance services to your application code: compliant logging, secure communications, configuration management, and audit-grade data handling.
Foundation Core's regulatory SDK extends the compliance boundary beyond the chip and into your firmware. By calling Foundation SDK functions, your application inherits the compliance properties of the underlying platform.
The SDK exposes compliant logging, secure communications, configuration management, real-time clock synchronisation, and audit-grade data handling directly to your application code. This enables the whole device firmware to benefit from Foundation's pre-certified infrastructure without the developer needing to build or document these services independently.
“Foundation Core packages regulatory infrastructure into a single Nordic nRF5340, certified once and reused many times. The customer’s application talks to Foundation Core over SPI. From their perspective, they are buying a compliant communications component, not undertaking a regulatory programme.”
For applications requiring the highest levels of safety assurance, Foundation extends across three Nordic SoCs. This architecture addresses the safety requirements of IEC 60601-4-5:2021 for programmable electrical medical systems.
Multi-processor architecture (patent pending, filed with Reddie & Grose LLP)
Foundation Core is designed to address the requirements of the following international standards for medical device software, safety, cybersecurity, and quality management.
Foundation Core provides transparent switching between connectivity technologies without changes to the customer's application code.
Foundation Core is part of a complete platform that provides medical device OEMs with everything needed from chip to cloud.
The nRF5340-based Regulation on Chip device. Pre-certified communications, logging, security, and safety monitoring as an SPI peripheral.
Secure backend for device management, data collection, and clinical reporting. Digital twin creation and lifecycle management.
Web-based administration interface for device fleet management, firmware distribution, and compliance monitoring.
Foundation Core has been supplied on Nordic nRF5xxx development kits to the University of Cambridge Department of Engineering for six consecutive years as part of the university's medical device project programme.
Final-year engineering students use the platform for projects that count towards their degree, introducing future engineers to both the Nordic development ecosystem and the practicalities of medical device regulatory compliance.
Foundation Core supplied to Cambridge Department of Engineering on Nordic development kits.
Fully functional temperature monitoring system with Android app, enterprise logging, secure OTA, and cloud integration.
Speak with our engineering team about how Foundation Core can accelerate your connected medical device programme.