Abstract
Medical devices have to provide efficacy and the benefit must outweigh the risk. In design development phase, we should adequately evaluate effectiveness and safety with assuring quality. Since effectiveness and safety of medical device are affected by user technique and combined medical device and drug, it is necessary to fully understand the characteristics of medical device under development. Risk management (risk analysis, assessment and control) are conducted based on defined characteristics. Items needs risk control must be evaluated for the machinery and appliances. Although there is no direct relativeness, insurance coverage and marketing strategy (usability, indication of differentiation from other products, etc.) after marketing approval should be considered during selection of evaluation items and methods.Additionally, we should consider and take measures for ensuring reliability, appropriateness and adequacy during above mentioned process.
