A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

An embedded system is a computer system—a combination of a computer processor, computer memory, and input/output peripheral devices—that has a dedicated function within a larger mechanical or electronic system. It is embedded as part of a complete device often including electrical or electronic hardware and mechanical parts. Because an embedded system typically controls physical operations of the machine that it is embedded within, it often has real-time computing constraints. Embedded systems control many devices in common use. In 2009, it was estimated that ninety-eight percent of all microprocessors manufactured were used in embedded systems.