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# Camgenium launches Foundation Platform for connected medical device development
- URL: https://med-techinsights.com/camgenium-launches-foundation-platform-for-connected-medical-device-development/
- Published: 2026-07-01T10:22:51.000Z
- Updated: 2026-10-22T07:54:40.000Z
- Description: Camgenium has announced the launch of its Foundation Platform, a pre-certified infrastructure spanning firmware, cloud and compliance for connected medical device manufacturers. The platform provides security, connectivity, regulatory infrastructure and cloud hosting as a ready-built foundation, and
- Author: Oliver Johnson
- Tags: Digital Health & AI, News

[**Camgenium**](https://www.camgenium.com/?ref=med-techinsights.com) has announced the launch of its Foundation Platform, a pre-certified infrastructure spanning firmware, cloud and compliance for connected medical device manufacturers. The platform provides security, connectivity, regulatory infrastructure and cloud hosting as a ready-built foundation, and allows OEM development teams to focus their engineering effort on clinical differentiation rather than building the compliance infrastructure from scratch according to the company.

Foundation addresses enginering challenges 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. Each device is assigned a dedicated cloud microservice at provisioning, enabling context-aware AI model delivery, FHIR integration and over-the-air firmware management..

Foundation Reporting completes the compliance picture by generating twelve categories of regulatory report, 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.