Safety-driven software reliability allocation in medical device application

Software reliability allocation deals with setting reliability objectives and allocating testing resources for software components or sub-systems. The whole allocation process is complicated as many factors, such as cost, complexity, maintainability, and etc, are included for consideration and there are many uncertainty resources. In this paper, a simplified approach is presented. The approach starts from safety features which are the top concerns in medical device applications; allocates reliability to components associated with safety features via utilizing analytic hierarchy process and fault tree analysis; and finalizes the allocation by combining the reliability contribution from all safety features. The approach makes some reasonable approximations to simplify the allocation process and resolve the problem fast and more efficiently. The allocation result is conservative and practicable in medical device applications.