Episode Details

In this lesson, we dive into the foundational principles of risk management, an essential discipline for ensuring safety and reliability in medical software. Discover why no software can guarantee 100% safety, and how risk management provides a systematic approach to identify, evaluate, and control potential hazards throughout the entire product lifecycle, from design to retirement. We'll explore key definitions and established standards that guide engineers in proactively addressing what can go wrong to minimize harm.

🎯 Learning Objectives
• Define key terms such as harm, hazard, hazardous situation, and risk within the context of medical software.
• Understand the systematic process and core components of risk management as outlined in standards like ISO 14971.
• Recognize that risk management is an continuous process integrated across all phases of the medical software lifecycle.
• Identify various categories of hazards and risks that can impact medical software, including user, application, device, environment, and security risks.
• Appreciate the significant impact of risk management on a company's operations, reputation, and overall business strategy.

Learn more about your ad choices. Visit megaphone.fm/adchoices