ABSTRACT
Hazard and risk analysis is a methodical approach to assist in designing safe and efficient medical devices. Casually the terms hazard and risk are often used synonymously. The hazard and risk analysis will have to consider the entire system including necessary or optional accessories and sub-systems. The specification of safety requirements, the evaluation of hazard mitigating measures and the verification and validation of safety-related functions of a device solely depend on the completeness and correctness of the hazard and risk analysis. The purpose of a hazard and risk analysis is to identify all possible hazards potentially created by a device, process or application. The fault tree analysis (FTA) is a methodology that can be used to trace hazards to possible component failures. FTA is call a top-down methodology because the starting point of each branch is a system level event, which is than decomposed into more detailed branches and sub-branches.
