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In this lesson, we delve deeper into software development life cycles, exploring the precise steps defined by the IEC 62304 standard. We'll also examine how modern agile methodologies integrate with these rigorous regulatory requirements, ensuring both efficiency and safety in medical software development. 🎯 Learning Objectives • Describe the key phases of the software development life cycle as per IEC 62304. • Differentiate between the development and maintenance life cycles for medical software. • Analyze the compatibility of agile methodologies with the structured requirements of the IEC 62304 standard. • Explain the importance of design controls and discipline in any medical software development process.
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