The client had developed the chemistry and a proof-of-concept prototype for an in-field HIV CD4 testing system. The assignment was to develop a portable electromechanical version for clinical testing as a beta version for the upcoming high-volume production model.
We were tasked with developing the centrifuge portion of the machine. We designed, prototyped, and tested the drive system, gimbal, and the centrifuge locking mechanism.
We helped build the beta units and performed end-of-line testing.
The design was put under strict revision control in order to meet FDA requirements for medical devices. We helped establish a design control system that managed document and change control.