The focus of this paper is defining two approaches such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) techniques to identify potentially hazardous software faults and development of software safety for clinical programming software (CPS) as medical device software. Software for medical systems has to deal with the Health software lifecycle identified by safety analysis in order to make the system safe. As the use of software in medical devices has improved, the need for specific regulations for healthcare system software has improved.
A lot of research is going on to improve the performance of bionic systems in respect of achieving near 100% functionality, low cost and smaller sizes with higher reliability and safety. Algorithms for controlling bionic system are based on the specific bionic devices like bionic ear with sound processing software and bionic eye with image processing software. Abstract Software Safety Analysis for Clinical Programming Software of Cochlear Implant SystemĬomputer based bio-electronic systems are used for replacement of damaged human parts such as Bionic-ear for deafness, Bionic-eye for blindness, Deep Brain Stimulator for diseases of the brain, and Bionic-arm for arm prostheses.
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