Industries
IEC 62304 / FDA
Medical Devices & Health Tech
Class C SoftwareSafety-critical embedded Linux
Overview
Medical-grade embedded systems demand deterministic real-time behavior, cryptographic boot chains, and full audit trails. Spikedge architects BSPs and RTOS layers that meet IEC 62304 Class C requirements from day one.
⚡Engineering Challenges
- Deterministic latency for sensor acquisition and actuator control
- Secure OTA updates with rollback protection in FDA-regulated environments
- Long-term BSP maintenance (10+ year product lifecycle)
- Integration with medical protocols (HL7, DICOM, CAN-FD)
Relevant Capabilities
Yocto BSP & Embedded LinuxHard Real-Time & RTOSSecure Boot & OTA
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