Compliance proves your device is secure. Guardian makes it secure — PKI-based cryptography, device identity, and key management built for medical devices with limited connectivity, limited memory, and clearances you can't afford to disturb.
Works from embedded MCUs up to servers, and in offline or air-gapped settings where keys have to be provisioned by hand.
A drop-in agent adds cryptographic security to existing devices without modifying source code or affecting your FDA clearance.
Provision, rotate, and manage certificates from the manufacturing line through years of field service.
Confidentiality, integrity, and authenticity of data — in transit and at rest — are squarely in scope. Guardian delivers them as built-in functions.
Secure your installed base without re-clearing it. Drop-in cryptographic security protects the investment you've already shipped.
Automated provisioning workflows replace spreadsheets and one-off processes, including for devices that never touch the internet.
Embed the Guardian library in your source, or install the agent with minimal impact to your R&D process.
Issue unique keys and certificates whether devices are connected or fully disconnected, with USB-based provisioning for air-gapped builds.
Rotate certificates, sign and verify updates, and lean on Guardian to simplify postmarket management and incident response.
PKI-based cryptographic identities and certificate-based authentication, so only authorized devices communicate within your ecosystem.
Protection for data in transit and at rest, across device-to-device and device-to-cloud connections.
Sign and verify firmware, configurations, and updates before they load — so nothing runs on the device that you didn't authorize.
Drop-in cryptographic security for existing devices, preserving the FDA clearances you already hold.
Guardian abstracts the hard parts of cryptography — key generation, PKI, provisioning — into functions your team can call, with FIPS 140-2 and 140-3 Level 3 compliant key generation and the flexibility to run from constrained embedded targets to cloud infrastructure.
PKI & certificate lifecycle · FIPS 140-2 / 140-3 Level 3 · Offline & air-gapped provisioning · Preserves existing FDA clearances · Section 524B aligned
Talk through your architecture and provisioning constraints, and see how Guardian fits the device you're actually building.
See Guardian