In this lecture from Yale's Introduction to Medical Software, the instructor begins a guided tour through the critical aspects of building software intended for clinical use, focusing on the interconnected topics of regulation, risk management, and lifecycle planning. The session explains why medical software must be developed under stricter oversight than typical consumer applications, given the potential consequences of failure for patient safety. Students are introduced to how regulatory requirements shape development decisions from the earliest design stages, and how risk assessment and lifecycle planning are treated as ongoing disciplines rather than one-time checklist items. The lecture sets the technical and compliance foundation the course builds on in subsequent sessions covering specific regulatory bodies and standards.