Executive Summary
A US healthcare innovator specializing in early detection of diseases like COVID-19 and early-stage cancers sought an engineering partner to create a high-throughput device for widespread testing. The client aimed for controlled access in public areas like hospitals, stadiums, offices, and mass transit.
The eInfochips team, with its deep engineering expertise in medical device development, helped the client with the design and development of the system – including hardware, firmware, FPGA components and mechanical enclosure. The team facilitated the seamless transition of the client’s research and Proof of Concept (POC) product into a fully-fledged commercial system. Notably, this system was meticulously crafted to adhere to stringent medical regulatory standards, namely ISO 13485 and IEC 62304.
The result of this collaborative effort is a cutting-edge solution that not only aligns with the client’s vision of proactive disease detection but also meets the rigorous demands of the medical regulatory landscape.
Project Highlights
- Filter circuit design to meet 1.5uV peak-to-peak noise
- Accurate measurement of all band EEG signals
- STM32 controller firmware development
- ISO 13485 and PDMA compliant design