Sterling Medical Devices participated in the development of a Class II blood analyzer system with Moderate Level-of-Concern software. The diagnostic system is composed of an embedded device coupled with programmer/user interface units and included problem domain technologies. In order to meet an ambitious timeline we proposed an aggressive schedule that did not compromise core functionality or safety. We developed and remediated tertiary hardware, GUI, focus, counting and Flash/Boot/USB functions. We also developed a PC Counting application to facilitate the development of the counting algorithm, imaging subsystem, and biochip. This began by reviewing requirements for the PC Counting Program and performing a full gap analysis. We then implemented the support processor, motor control, imaging processor, and main control processor and performed software verification and validation. We developed a full DHF to support FDA submission for 510K, which was approved. Development was performed under Sterling’s QMS then transferred to the client’s QMS.
