The steps of a complex process can be displayed in sequence using a graphic referred to as a process flowchart. The graphic explains the way a process is or should be functioning, depending on the ...

Designed to address the needs of users and patients. Designed to meet inputs and requirements. Proven to meet applicable standards. Meets performance criteria. Realize Design Controls and Risk ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...