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Explore the fundamental principles of medical software development through regulatory classifications, risk assessment, and lifecycle management in this 12-minute lecture from Yale University. Delve into how medical software is classified based on regulatory risk levels and examine the complex healthcare environment with its critical data privacy and security requirements. Learn about Quality Management Systems and robust Risk Management processes that form the backbone of safe medical software development. Discover the medical software lifecycle using the V-model approach, illustrated through a real-world neurosurgery case study that demonstrates the progression from understanding user needs to defining concrete software requirements. Master the essential skills needed to classify medical software by risk, identify key environmental factors affecting healthcare software, explain quality and risk management principles, analyze user needs through usage scenarios, and describe the initial phases of medical software development lifecycle.
