For medical device software development organizations, it is very challenging to maintain
both conformance to the strict regulatory requirements enforced by the safety-critical nature …

Agile methods have provided significant contributions to Software Engineering. This work
presents a new process for Software Requirements Specification, integrating Agile …

Nowadays, medical devices rely on software whether completely such as mobile medical
applications or as embedded software into medical chips such as tele surgery systems …

Quality is a major concern in Medical Device Manufacturing (MDM). Conformance with
prevailing regulatory standards is of profound importance in MDM. Due to critical nature and …

Project failure remains high for software development projects. The purpose of this research
was to contribute to the body of knowledge pertaining to the use of software development …