What is the role of IEC 62304 in medical device software development?

• A. It defines a software life cycle process for medical device software, including software safety classification, life cycle processes, and activities for development, maintenance, and risk management.
• B. It sets electrical performance criteria for software-driven devices.
• C. It establishes requirements for human factors in software design.
• D. It governs the validation of hardware components.

Answer: (D)

IEC 62304 defines the required software life cycle processes for medical device software, including how to classify software safety risk and the activities needed across development, maintenance, and risk management. It provides a structured framework for planning the software life cycle, gathering and refining requirements, designing and implementing software, and verifying and validating it, all with explicit configuration management, problem reporting, and change control. A key aspect is its link to risk management, requiring traceability between software safety classifications, development activities, and verification results within the overall risk management process. This ensures that software safety decisions drive the level of rigor and documentation throughout development and after changes. It does not set electrical performance criteria, establish human factors requirements, or govern hardware validation; those areas are covered by other standards such as IEC 60601-1 for electrical safety and IEC 62366 for usability.