Medical software is any software item or system used within a medical context, such as:
standalone software used for diagnostic or therapeutic purposes;
software embedded in a medical device (often referred to as "medical device software");
software that drives a medical device or determines how it is used;
software that acts as an accessory to a medical device;
software used in the design, production, and testing of a medical device; or
software that provides quality control management of a medical device.