Medical Device Software Lifecycle using IEC 62304
Hello Folks✌ When we think about medical devices, we often imagine hardware such as ECG machines, infusion pumps, or imaging systems. But have you noticed something common among modern medical devices? 👉 Most of them rely on software. Whether it's displaying patient data, controlling device functions, generating alarms, or analyzing medical information, software plays a critical role. And when software is involved in patient care, even a small error can have serious consequences. That's why the medical device industry follows a dedicated software lifecycle standard called IEC 62304 . What is IEC 62304? IEC 62304 is an international standard that defines how medical device software should be developed and maintained throughout its lifecycle. In simple terms: 👉 It provides a structured framework for building safe and reliable medical device software. Think of it as a roadmap that guides software teams from planning to maintenance. Why Do We Need IEC 62304? Imagine ...