The integration of a formal safety analysis into the future software engineering process: An example from the pacemaker industry

An example from the cardiac pacemaker industry of safety-orientated software-design methodology is provided. Safety consideration begins upon product description with a hazard analysis whereby potential hazards are classified according to their criticality and rough probability of occurrence. The completed hazard analysis determines the software safety requirements which specify what the system will not do. A system-hazard cross-check matrix is defined that serves to direct the design team to those areas requiring more scrutiny. Traceability matrices provide a verifiable link from safety requirements design to the actual code. This methodology should serve to minimize hazards in the final software product