An enhanced agile-V model for system engineering in complex medical device development

Abstract

With the advancement in technology, the scope of medical devices extends from simple hardware machines to integrated hardwares with support of software systems which are themselves used either as medical device or to provide support. Regulatory bodies to ensure safety of both the hardware and software devised the rules to which these medical devices needed to adhere. To meet the constraints, the development of these medical devices either through Water fall model or through agile model is not very feasible. We proposed enhanced Agile V-model for the development of the complex medical devices and applied its recommendation in the development of our wave therapeutic device.