Sterling Medical Devices assisted in development of a Class III pump intended for use in apheresis, a process that requires filtering blood into plasma and cells. The pump pushes blood through a plasma separator. The major level of concern software, written in C, runs on a digital signal processor. Sterling performed independent code review, unit module tests, and review and update of the functional test protocols. Development was performed on Sterling’s ISO 13485 certified QMS then transferred to the client’s QMS.
