Medical device electronics
Prototype through verification planning
- Medical device
- Electronics
- Firmware
Problem: A portable diagnostic instrument needed custom power management, multi-channel sensing, and embedded processing on a regulated development path.
Contribution: Elfstone designed the power and sensing hardware, wrote the board firmware, and produced the verification evidence inputs for the IEC 62304 and 510(k) documentation set. The device reached design freeze with a complete verification evidence package.