International Journal of Engineering and Technology

Software is now becoming the primary differentiator for medical devices manufacturer. Software development is driven by the risks, stringent quality requirements (such as safety, reliability), regulatory challenges, market pressures and significant complexity. To balance these, medical device industries need effective software development process to satisfy their client’s need. This paper identifies the actual barriers associated with software practices during development of medical software. We have focused on some of the processes such as V-model, agile and formal methods which was currently followed in most industries. We analyzed the strengths and weaknesses of the various approaches employed in medical device software development. A closer examination of these processes indicates that there is a potential demand in the area of process improvement in the field of medical device software.