Product Overview
Respiratory and Critical Care Device Engineering
Engineering for life-support and critical care equipment. Our reference project is a portable battery-powered ventilator built from ten boards: respiratory control, oxygen and air mixing, capnography, battery management and user interface. The boards were split by hazard boundary, and the safety-critical respiratory control and gas mixing boards were frozen first, so the user interface could keep changing without reopening their verification.
We cover sensor and pneumatic control electronics, power and battery systems, alarm and safety logic in firmware under IEC 62304, IEC 60601-1 and IEC 60601-1-2 design, mechanical packaging for field use, test stands, and design transfer to the manufacturer. Large programs of this kind typically run 10,000 to 30,000 engineering hours.
ISO 13485:2016 certified quality system; $125 per hour.
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