Ever wondered what goes into creating safe and effective medical software? In this comprehensive lesson, we embark on the first part of a guided tour through the critical aspects of medical software development. We delve into regulatory classifications based on risk, explore the intricate healthcare environment and vital data privacy/security concerns, and introduce core concepts like Quality Management Systems and robust Risk Management processes. This segment also kicks off our journey through the medical software lifecycle using a real-world neurosurgery case study to illustrate the crucial steps from understanding user needs to defining concrete software requirements.
🎯 Learning Objectives
• Classify medical software based on regulatory risk levels.
• Identify the role of data privacy, security, and the healthcare environment in medical software.
• Explain the principles of Quality Management Systems and Risk Management in product development.
• Analyze user needs and formulate software requirements using usage scenarios.
• Describe the initial phases of the medical software life cycle (V-model).
