This article discusses basic concepts of risk management and regulation of medical devices. Risk management is a procedure to reduce the risks involved with a medical device whereas the regulation of medical devices is a public health tool to assure the safety and effectiveness of devices introduced into the market place. Both risk management and regulation are interrelated and take place throughout the entire life cycle of the device, from design through maintenance and obsolescence. As the risks associated with the use of a medical device may vary with the environment where they are used, (e.g., hospital, clinical, home), the risks must be identified and acceptance criteria established to assure that the device perform safely and effectively in its intended environment.