- Foundation Platform provides pre-certified firmware, cloud infrastructure and compliance reporting
- Enables connected medical device teams to focus on clinical innovation, not compliance infrastructure
- Reduces development complexity while supporting secure, scalable and regulatory-compliant deployment
Camgenium has announced the launch of its Foundation Platform, a pre-certified infrastructure spanning firmware, cloud and compliance for connected medical device manufacturers. By providing security, connectivity, regulatory infrastructure and cloud hosting as a ready-built foundation, the platform allows OEM development teams to focus their engineering effort on clinical differentiation rather than building the compliance infrastructure from scratch.
Building a connected medical device means solving two separate engineering challenges simultaneously. Addressing these requirements from scratch is slow and expensive, demanding specialist expertise across firmware security, cloud infrastructure, regulatory affairs and quality management that is rarely held in full by a single development team. The clinical proposition demands deep domain expertise. But before a single line of clinical code can be written, teams face years of infrastructure work: secure boot, hardware-backed encryption, key management, over-the-air firmware distribution, device-to-cloud connectivity, and audit-grade logging. These systems must also meet regulatory expectations from day one, with documentation embedded throughout the design process.
Focus on clinical innovation, not compliance infrastructure
Foundation addresses this through a complete, pre-certified platform spanning the full hardware and software stack. At the centre is Foundation Core; Camgenium’s Regulation on Chip (RoC), pre-certified firmware for the Nordic nRF5340 system-on-chip which delivers IEC 62304-compliant communications, audit-grade logging, secure boot, encrypted over-the-air firmware updates and independent safety monitoring as a standard SPI peripheral. The customer’s application processor communicates with Foundation Core over SPI, inheriting its compliance properties without the cost and complexity of building or documenting those services independently. All clinical code, algorithms and domain-specific innovation remain the customer’s intellectual property; Foundation is the infrastructure they use, not the IP they licence.
Connected devices communicate with Foundation Cloud, Camgenium’s own medical-grade cloud infrastructure, developed to IEC 62304 Class B medical device software standards and operated to ISO 27001. Camgenium operates its own servers in the UK and US, with EU infrastructure in deployment, providing full data residency control alongside compliance with NHS DSPT, HIPAA, SOC 1, SOC 2, GDPR and Cyber Essentials. Cloud connectivity is included within the Foundation Core licence at no additional charge. Each device is assigned a dedicated cloud microservice at provisioning, enabling context-aware AI model delivery, FHIR integration and over-the-air firmware management across the full device fleet.
Automate compliance across the product lifecycle
Foundation Reporting completes the compliance picture by generating twelve categories of regulatory report, automatically and continuously covering device integrity, risk control status to ISO 14971:2019, software bill of materials (SPDX 2.3), AI model governance to ISO 42001:2023, fleet security and cloud infrastructure compliance. Evidence that would require sustained effort across regulatory affairs, cybersecurity, firmware engineering and machine learning specialisms is produced from live system telemetry, without manual data entry or retrospective documentation. The platform is continuously maintained against the requirements of IEC 62304:2006+AMD1:2015, ISO 13485:2016, ISO 27001:2022, IEC 60601-4-5:2021, IEC 81001-5-1, EU MDR 2017/745, FDA QMSR and UKCA.
“Foundation Core packages the regulatory infrastructure that every connected medical device needs, secure boot, compliant communications, audit-grade logging into a single Nordic chip, certified once and reused many times,” said Dr Philip Gaffney OBE, Chief Executive Officer of Camgenium. “The customer’s application talks to Foundation Core over SPI. From their perspective, they are acquiring a compliant communications component, not undertaking a regulatory programme.”
Early versions of the Foundation Platform have been supplied to the Cambridge University Department of Engineering for six consecutive years, where final-year students use the platform on Nordic development kits for degree-counted medical device projects. The platform is available to connected medical device manufacturers under a long-term partnership model, with SaaS pricing structured per active device under management and inclusive of connectivity, all twelve report types, software maintenance, security patches and regulatory alignment updates. Camgenium partners with customers for the full product lifecycle, from prototype through certification, deployment, post-market surveillance and decommissioning.
To learn more about Foundation Platform, visit: https://www.camgenium.com/foundation/
