A Critical Review on Hazard Analysis and Risk Assessment for Development of Wearable Medical Devices

Many patients suffer from variable chronic illness. In the past, the patients are required to carry out health check in half year or yearly interval. However, the result is only to reflect the instantaneous health index, for example the glucose level in blood. The wearable medical device is a good solution to the medical doctors to understand the patient’s continuous health status. This paper aims to review the different hazard analysis and risk assessment approaches for developing the wearable medical devices. In the beginning, the need for wearable medical devices is discussed, Secondly, the typical product development cycle is reviewed, Thirdly, different hazard analysis and risk assessment approaches are reviewed and summarized. Finally, a conclusion is made to recommend to the developers.