Lattice OS 4, the embedded operating system that runs on Axon Sense, Fieldmesh, Nexa Edge, and Lattice bench systems, has completed an independent assessment against IEC 62304 for Class C medical device software.
Class C is the classification applied where a software failure could contribute to death or serious injury. It is the strictest of the three, and it sets requirements on the whole development lifecycle rather than on the finished artifact: architecture, risk management, unit verification, integration testing, configuration management, problem resolution, and the handling of software of unknown provenance.
What was assessed
- The Lattice OS 4 kernel, scheduler, and memory management.
- The device abstraction layer and the driver framework.
- The secure boot chain and update mechanism.
- Our development lifecycle processes, including the traceability from requirement to test.
- Our handling of third-party and open-source components, including the cryptographic library.
What was not
The assessment covers the platform. It does not cover any individual device built on top of it, and it does not substitute for the regulatory work each device has to do in its own right. A device manufacturer using Lattice OS still has to make its own case; what this changes is how much of the platform layer they have to make it about.
Availability
The assessment report, the traceability matrix, and the software bill of materials for Lattice OS 4 are available to customers and to partners building on the platform. They are provided under a non-disclosure agreement, which is standard for this kind of material and is not a comment on its contents.
Existing devices are unaffected. Lattice OS 3 remains supported until December 2028.
Requests for the assessment package should go through your account team.