The Foundation Platform is a pre-certified infrastructure for developing medical devices. We have taken care of the security, connectivity, compliance and cloud requirements, ensuring our clients can focus on clinical innovation. Camgenium's team of expert engineers mentor and upskill your team with the regulatory knowledge required for developing regulated medical devices.
Before you write a single line of clinical code, you face years of infrastructure work that has nothing to do with your core innovation.
Secure boot, hardware-backed encryption, key management, TLS connectivity. Each one a specialist discipline. Getting any of them wrong invalidates your entire submission.
IEC 62304, ISO 14971:2019, ISO 13485:2016, EU MDR, UKCA. Compliance documentation must be woven into every line of code from day one; it cannot be bolted on at the end.
Secure device-to-cloud communication, OTA firmware updates, device management, data storage. Building this to medical-grade standards takes as long as building the device itself.
Every month spent on infrastructure is a month not spent on your clinical proposition. Investors see costs rising and time to market narrowing, with no visible product progress.
Most contract development houses charge for effort. We have already spent years building the infrastructure your device needs. That changes everything.
Each project begins with months of platform setup, security architecture and cloud infrastructure. You pay for all of it.
Regulatory documentation is created retrospectively, often at great cost, and frequently fails to satisfy notified bodies.
The relationship ends when the project ends. Ongoing maintenance, updates and regulatory obligations fall entirely to you.
Your team inherits code they did not write, with knowledge that left when the contractors did.
Security, connectivity, compliance and cloud are already built, tested and warranted. You begin where your clinical innovation starts.
Every line of Foundation code carries auditable compliance evidence. Regulatory documentation is generated continuously, not bolted on.
Ongoing software maintenance, OTA updates, compliance monitoring and regulatory reporting for as long as your device is in the field.
We fill the skills you lack, train your engineers, and ensure all clinical IP remains entirely yours.
A complete medical device infrastructure spanning the full data path. The platform covers sensor inputs through device firmware, cloud to server-side device management and regulatory reporting.
Pre-certified firmware for Nordic nRF5340 with secure boot, hardware encryption, watchdog safety monitoring and SPI peripheral management.
Explore Foundation Core →Medical-grade cloud infrastructure for secure device communication, data storage, OTA firmware delivery and real-time monitoring.
Explore Foundation Cloud →Pre-built mobile and web application frameworks for patient-facing and clinician-facing device interfaces.
Explore Foundation Apps →HSM-backed secure manufacturing-time device identity injection with full audit trail and traceability.
Explore Foundation Provisioner →Automated compliance reporting, device fleet management, asset tracking and regulatory submission preparation.
Explore Foundation Reporting →Programmatic access to qualified device data, compliance services and fleet management for integration with your own systems.
Explore Foundation API →We work alongside you at every stage, filling the gaps in your team and building capability that stays with your organisation.
We understand your clinical proposition, your team's strengths and the gaps that need filling. No commitment, no charge; just an honest assessment of whether Foundation is the right fit for your project.
Your device architecture is mapped onto the Foundation Platform. We identify which components you need, define interfaces to your clinical code, and produce a development roadmap with realistic timelines.
Your team focuses on clinical innovation while Foundation handles infrastructure. We work alongside your engineers, transferring knowledge and building their capability throughout the process.
Regulatory submission preparation is straightforward because compliance evidence has been accumulating since day one. We support you through the notified body process with documentation that is thorough and auditable.
Devices go into the field with ongoing software maintenance, OTA updates, compliance monitoring, post-market surveillance support and regulatory reporting. We are your long-term partner, not a short-term supplier.
We succeed when your device succeeds in the market. Our model is built around long-term commitment, not short-term billing.
All clinical code, algorithms and domain-specific innovation remain your intellectual property. Foundation is infrastructure you use, not IP you license.
We train and mentor your team throughout the partnership. When your engineers grow in knowledge, your organisation grows in value.
Automated regulatory reporting, software maintenance and protection against changes in standards and regulations, for the operational life of your device.
Our revenue model is built on long-term partnership. We are motivated to ensure your device reaches market and remains there successfully.
Camgenium (L2S2 Ltd) has been developing and deploying medical software from Cambridge for over twenty years.
The Foundation API is Software as a Service (SaaS) available to Partners. All tiers include full API access. Pricing reflects the number of active devices under management. No hidden charges, no per-call metering, no surprises.
For products entering the market with initial deployments.
For established products scaling across markets and territories.
For large-scale deployments with bespoke requirements.
Every Foundation service, from the platform partnership through to the API, is designed so that you can model your total cost of ownership at the outset. No metered API calls, no bandwidth charges, no surprises at scale.
One rate per active device per month. Simple to model, simple to forecast.
Device-to-cloud data transport is included. No bandwidth metering.
All 12 report types, SBOM, SOUP, CVE monitoring, and audit trails are part of your tier.
Software maintenance, security patches, and regulatory alignment updates at no additional cost.
Whether you are an engineer evaluating the platform, a founder building a business case, or an investor assessing the opportunity, we have detailed information for your perspective.
Architecture documentation, SDK references, integration guides and technical specifications for every Foundation Platform component.
engineering@camgenium.com →Business case materials, partnership models, IP protection details and how Foundation accelerates your route to market and regulatory clearance.
commercial@camgenium.com →How Foundation de-risks medical device development, protects portfolio company IP and creates predictable paths to regulatory approval.
investors@camgenium.com →Most development partners want to stay indispensable. We do the opposite: structured programmes that transfer regulatory compliance, embedded security and connected device knowledge directly to your team.
training@camgenium.comWe commit to our partnerships and invest in our customers for the long term. If you are building a connected medical device and want to understand whether Foundation is the right fit, we would welcome the conversation.