Biomedical engineering work is subjected to stringent regulatory constraints that mandate a robust engineering process that conforms to all pertinent regulatory guidelines and imperatives.
Software development is an important component of any engineering project and as such, it should be equally addressed and properly integrated with the overall engineering process. To that effect, the following software development process is proposed. This process attempts to be well grounded in the nature of innovative Biomedical engineering work. There are inherent significant technology risks related to the development of innovative biomedical devices. These risks must be correctly identified, and mitigated throughout the entire engineering process. The main benefit of the software development process presented here is its explicit management of software risk factors as recommended by modern successful software development practices.