Have you ever wondered what it takes to bring medical software to market safely and legally? In this lesson, we demystify the essential regulatory process for medical devices, from initial design and risk analysis to FDA approval and beyond. We explore the nuanced definition of a medical device, distinguishing regulated software from general healthcare applications, and delve into the critical role of laws, regulations, and international standards in ensuring product safety and developer accountability.
🎯 Learning Objectives
• Understand the comprehensive steps of the regulatory process for medical software development.
• Accurately define a medical device and distinguish it from non-regulated healthcare software.
• Differentiate between laws, regulations, and guidance documents in the regulatory framework.
• Recognize the significance of international standards (soft law) in medical device compliance.
