Foundation Cloud

Compliant infrastructure that just works

Foundation Cloud is pre-deployed, standards-compliant hosting for connected medical devices. It is managed as a medical device, developed to IEC 62304 Class B, and operated to ISO 27001:2022. Connectivity is included in the Foundation Core licence; there is no separate charge.

Foundation Cloud
Device MicroserviceDedicated per device
AI Model StoreCloud-validated models
Context EnginePatient coding / EHR
OTA ManagerFirmware distribution
Asset RegistryCompliance tracking
Report EngineRegulatory reports
TLS 1.3 · mTLS · Encrypted
Physical Devices
Device A
Device B
Companion App
Each device has a dedicated cloud microservice
Foundation Platform
Class 2
Infrastructure classification
IEC 62304
Software lifecycle standard
£0
Separate connectivity charge
24/7
Managed and monitored

Why Foundation Cloud

Foundation Cloud removes the cost, risk, and regulatory complexity of building and maintaining your own compliant hosting infrastructure. It is ready when you are, and it is managed as a medical device so that you do not have to manage it yourself.

Pre-deployed and ready

There is no infrastructure to build. Foundation Cloud is operational before you begin development. Your devices connect to a compliant, monitored environment from day one, with no procurement delays or setup costs.

Managed as a medical device

The cloud backbone microservices are developed to IEC 62304 Class B medical device software standards. This is not standard commercial cloud; it is purpose-built infrastructure where every change is controlled, documented, and validated.

Standards-compliant by design

Infrastructure is certified to ISO 27001:2022, GDPR, Cyber Essentials, and in the US, SOC 1, SOC 2, and HIPAA. In Canada, PIPEDA. Your devices inherit this compliance posture, significantly reducing the scope of your own regulatory submissions.

International data residency

Camgenium operates its own servers in the UK, Canada and US, with additional jurisdictions being deployed. Data stays where it needs to stay, and data privacy laws are followed in each territory.

Isolated from external change

When large cloud providers change their terms, pricing, APIs, or compliance posture, Camgenium absorbs the impact. You are insulated from infrastructure disruption; we manage change and keep the platform compliant.

Hospital governance support

Deploying connected devices into NHS trusts and hospital networks requires navigating local IT governance, information security questionnaires, and data processing agreements. We have experience of this process and help customers achieve rapid acceptance.

Connectivity included in the Foundation Core licence

There is no separate charge for cloud connectivity. When a customer licences Foundation Core (Regulation on Chip), cloud connectivity to Foundation Cloud is included. This simplifies budgeting, eliminates per-device connectivity fees, and removes the need to negotiate separate hosting contracts.

The hybrid instrument

Foundation Cloud treats each connected device as a hybrid instrument. Part of the instrument runs on the physical device; part runs in a dedicated cloud microservice. This is not simply data storage or a dashboard; the cloud component can be an active part of the instrument's function.

The device's dedicated microservice can access cloud resources that the physical device cannot: the patient's current medical condition (via clinical coding systems), cloud-validated AI models, population-level analytics, and integration endpoints such as FHIR. Context information from these sources can be used to push appropriate models to the physical device, creating personalised instruments tailored to each patient's clinical situation.

Even when context-aware functionality is not required for a given application, this architecture ensures smooth scaling and provides resilient communications for critical applications. The backend tracks device allocations and can transfer instructions and data to physical devices without human intervention.

Cloud Instrument Component
Dedicated microservice
Patient context
AI model selection
FHIR integration
Population analytics
OTA management
Encrypted bidirectional • Context-aware model push • Command & data transfer
Physical Instrument Component
Foundation Core
Sensors
Edge AI inference
Local processing
BLE / Wi-Fi / Cellular
Each device receives a dedicated cloud microservice at provisioning

Over-the-air updates, under complete control

Foundation Cloud manages the distribution and tracking of firmware updates across your entire fleet. Updates are applied in a context-sensitive manner that avoids disruption, and every update is fully asset-tracked to meet compliance obligations.

Managed distribution

Firmware images are distributed from Foundation Cloud to devices securely. The platform tracks which devices have received each update, which are pending, and which require rescheduling. Distribution is managed by Camgenium; there is no manual coordination required.

Context-sensitive scheduling

Updates are applied at appropriate times based on device state and usage context. A device in active clinical use is not interrupted mid-procedure. The platform understands device state and schedules updates for safe application windows.

Full asset tracking

Every update is recorded against the device's asset record, including the firmware version deployed, the timestamp of application, and the verification result. This provides the complete firmware provenance trail that regulatory authorities require.

Rollback capability

If an update fails verification or causes an operational issue, devices can be rolled back to the previous verified firmware version. The dual-slot architecture supported by Foundation Core enables safe rollback without service interruption.

Data stays where it needs to stay

Camgenium operates its own server infrastructure in each jurisdiction, ensuring compliance with local data privacy and sovereignty requirements. You do not need to negotiate data processing agreements with third-party cloud providers.

United Kingdom

Camgenium-operated servers. UK GDPR, Cyber Essentials, NHS Data Security and Protection Toolkit compliant.

Live

United States

Camgenium-operated servers. SOC 1, SOC 2, and HIPAA compliant with BAA in place. FDA 21 CFR Part 11 compatible audit trails.

Live

European Union

EU GDPR compliant infrastructure. EU MDR 2017/745 compatible reporting. Additional jurisdictions in deployment planning.

Coming soon

Isolated from provider changes

When AWS, Azure, or GCP change their terms of service, pricing models, data handling policies, or API interfaces, Camgenium absorbs the impact. Your devices continue to operate against a stable, managed interface. We handle the migration work so that you never have to.

Managed compliance maintenance

Regulatory requirements change. New versions of ISO 27001:2022, updates to HIPAA, evolving GDPR interpretations: Camgenium monitors, assesses, and implements changes to maintain continuous compliance. Your infrastructure is always current without any effort from your team.

Getting into hospitals, quickly

Deploying a connected medical device into an NHS trust or hospital network is not simply a technical exercise. Each organisation has its own information governance framework, IT security requirements, data processing agreements, and approval processes. These can delay deployment by months if navigated without experience.

Camgenium has been through this process with NHS hospitals and understands what is required: DSPTs, DPIAs, DCB0129, Clinical Safety Cases, network architecture documentation, and governance board presentations. We work alongside customers to prepare the documentation and respond to the questions that hospital IT and IG teams will ask.

1

Pre-deployment documentation

Camgenium prepares the information security and data processing documentation that hospital governance teams require, based on proven templates from previous NHS deployments.

2

IG and IT engagement

We support technical discussions with hospital IT teams, providing network architecture documentation, data flow diagrams, and security control evidence from Foundation Cloud's certified infrastructure.

3

Governance board approval

We help prepare the case for governance board review, drawing on Foundation Cloud's ISO 27001:2022, Cyber Essentials, and DSPT compliance to demonstrate that the infrastructure meets organisational requirements.

4

Rapid deployment

With governance approval secured, devices connect to pre-deployed infrastructure immediately. There is no separate cloud setup phase; the infrastructure has been ready since provisioning.

“The best cloud infrastructure is the kind you never think about. Foundation Cloud is invisible by design: it is there when your devices need it, it is compliant in every jurisdiction you operate in, and it adapts to change without ever requiring your attention.”

Dr Philip Gaffney OBE Chief Executive Officer, Camgenium

Foundation Cloud that is ready when you are

Speak with our team about how Foundation Cloud can support your connected device deployment.

Contact our team Foundation Platform