Technology is widely used in medicine, in the form of Medical devices and Clinical engineering. These advancements come with risks, in the forms of hazards presented by the hardware or its failure, and the way that people use the hardware. There are significant regulatory requirements regarding the development of medical devices, though these are focused primarily on the technical systems, hardware reliability, hazard elimination, and quality assurance in manufacture. Comparatively less attention has been directed to human error.
The purpose of this project is to develop a systems engineering methodology to manage the risks during the development of medical devices, with a particular emphasis on incorporating means to determine the integrity of procedures and human actions in the NPD development process.