Organizational design is the process of creating the hierarchy within a company. The six elements of organizational design help business leaders establish the company departments, chain of command and ...
FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...
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 ...