Which standard defines a software life cycle process for medical device software, including safety classification, life cycle processes, and development activities?

• A. ISO 13485
• B. IEC 60601-1
• C. IEC 62304
• D. IEC 62366

Answer: (C)

IEC 62304 provides the framework specifically for the software life cycle of medical device software. It defines how software should be classified by safety risk and then prescribes the life cycle processes and development activities needed to manage that risk from concept through retirement. The safety classification guides the rigor of the required processes, documentation, and testing at each stage, ensuring that more critical software receives more thorough development and verification. Development activities covered include software requirements, architecture and detailed design, implementation, integration, verification and validation, maintenance, configuration management, problem resolution, and release management, all tied to risk management activities (often aligned with ISO 14971). This standard is distinct from ISO 13485, which covers overall quality management systems for medical devices, IEC 60601-1, which focuses on electrical safety, and IEC 62366, which addresses usability engineering.