Validation evidence is produced during development, or not honestly at all.
Medical systems are judged on the evidence behind them as much as on how they perform. That evidence cannot be assembled after the design has frozen.
WHAT THE WORK TURNS ON
- Design controls
- Traceability from requirement to verification, maintained as the design moves.
- Validation
- Evidence that the system does the clinical job, not only that it meets its specification.
- Data integrity
- What the device records, how it is protected, and what happens when the link is down.
- Safety-critical design
- Behaviour under fault defined at architecture, not discovered in test.
ARCHITECTURE
The architecture this sector draws on. It is the same system TrustXP builds in the corresponding domain — the sector changes what matters in it, not what it is.
IoT and embedded system architecture
- Device
- Sensor array and the embedded controller that reads it.
- Edge intelligence
- An RTOS and an inference layer deciding on-device.
- Cloud services
- Integration, device management and over-the-air update.
A sensor array feeds an edge controller running an RTOS and an inference layer. Connectivity carries data to cloud services, and a device-management path returns firmware and configuration over the air.
- Layer 1 of 3: Device. Sensor array and the embedded controller that reads it.
- Sensor array — Concern deterministic control loops
- MCU / SoC — Concern embedded firmware
- Peripherals
- Layer 2 of 3: Edge intelligence. An RTOS and an inference layer deciding on-device.
- RTOS — Concern edge inference latency
- Inference — Validation medical-device controls
- Layer 3 of 3: Cloud services. Integration, device management and over-the-air update.
- Connectivity
- Device management — Path OTA update
Connections:
- Sensor array reports readings to MCU / SoC.
- MCU / SoC drives Peripherals.
- MCU / SoC passes data up to RTOS.
- RTOS schedules Inference.
- Inference passes data up to Connectivity.
- Connectivity carries telemetry to Device management.
- Device management returns firmware and configuration to Inference.