ABSTRACT
Hazard and risk analysis is a methodical approach to assist in designing safe and efficient medical devices. Safety critical industries like nuclear, aerospace or chemical industries have used various approaches to assess hazards and minimize the risk potential of their installation or products for years. The earliest approaches have been to identify hazards after the basic design decisions have been made and successively mitigate or change the design to address potentially hazardous failure modes. Techniques like FTA and F1\1EA have been used extensively to achieve this goal. However the techniques employed during a hazard analysis try to accomplish this at an even earlier time during the development process!l thus allowing a more economical and speedier development process by developing valuable design information before the design process is initiated.
