Multi-Sensor Diagnostic Platform
MistyWest was asked to expand upon previous work we had done for Aeri Health by bringing their Cagiva pulse-oximeter product to market, of which we had already successfully researched, designed, and fabricated 3000 units in a timeline of 16 weeks. MistyWest integrated a new MCU into the PCB design and optimized for volume manufacture, including injection molded design of plastics, and delivered the first functional prototypes for testing and validation. The design performed under ISO 13485 standards for medical devices, including all QMS documentation.
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