Which standard governs the software life cycle processes for medical devices?

• A. IEC 60601-1
• B. ISO 13485
• C. ISO 14971
• D. IEC 62304

Answer: (D)

IEC 62304 defines the software life cycle processes for medical devices. It lays out the full lifecycle for medical device software—from safety classification and risk management to requirements, architecture, coding, verification, integration, and maintenance. It also covers change control, problem reporting, and configuration management, ensuring that software is developed and maintained in a structured, auditable way. This standard is designed to be used alongside ISO 14971 for risk management and IEC 60601-1 for device safety, while ISO 13485 governs the overall quality management system but does not specify software lifecycle activities. So, the standard that governs the software life cycle processes is IEC 62304.