IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities then further divided into a set of tasks.
As a basic foundation the standard assumes that medical device software is developed and maintained within a quality management system and a risk management system. The medical device risk management system is already covered by ISO 14971. So IEC 62304 references the ISO 14971 throughout the standard. However, some minor additional risk management requirements are needed for software, especially in the area of identification of contributing software factors related to hazards. These are covered by IEC 62304.
Whether software is a contributing factor to a hazard is determined as an activity of the risk management process. Hazards that could be indirectly caused by software (for example, by providing misleading information that could cause inappropriate treatment to be administered) need to be considered. The decision to use software to control risk is made during the risk control activity. Then the software risk management process required in this standard has to be embedded in the device according to ISO 14971.
Because many incidents in the field related to service or maintenance of medical device systems include inappropriate software updates and upgrades, the software maintenance process is considered to be as important as the software development process. So maintenance is covered by the standard as well.
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