Sterling Medical Devices participated in the development of Electroencephalography (EEG) Capture and Display system. EEG capture uses external electrodes placed on the scalp to capture electrical responses and monitor cognitive activity. Based on the voltage fluctuations of wavelengths displayed, analysis is completed for first-line diagnosis on neural abnormalities, such as epilepsy, brain death, and stroke.

Communication between the brain-computer interface (in this case, the ANI Interface) and the EEG software occurs through a USB connection. The interface processes the incoming data and extracts, filters, and derives necessary information for control, status, and data stream. This data is passed to the interface UI through the Software Development Kit. The system operates on both Microsoft Windows XP and 7 systems, coded in C++, and set in US-English. Provided all existing custom hardware, product/system, and device firmware documentation, Sterling developed and tested the needed ANI Interface Software to completion under FDA compliance.

The first phase focused on planning, prototyping, and developing requirements to create a comprehensive plan that effectively utilizes existing documentation for revision and reapplications. This plan is created to project schedule and software development, verification, and requirements. The second phase focused on design, implementation, and verification. This included a project software design document, software hazard and off the shelf analysis, building documents and a source code, along with a series of FDA-compliant documentation reports for unit model, verification, traceability, and an operation guide. Upon conclusion of the development phase, dry run testing was performed by our team under Sterling’s Quality Management System and then transferred to the client’s QMS for final review.