Industries

IEC 62304 / FDA

Medical Devices & Health Tech

Class C SoftwareSafety-critical embedded Linux

01Overview

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.

02Engineering Challenges

  1. 01Deterministic latency for sensor acquisition and actuator control
  2. 02Secure OTA updates with rollback protection in FDA-regulated environments
  3. 03Long-term BSP maintenance (10+ year product lifecycle)
  4. 04Integration with medical protocols (HL7, DICOM, CAN-FD)

03Relevant Capabilities

Yocto BSP & Embedded LinuxHard Real-Time & RTOSSecure Boot & OTA

To evaluate your Medical Devices & Health Tech needs on your own platform, schedule an embedded architecture audit or scope your platform class with the system requirements calculator.

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