11.5 | Navigating Singapore AI/ML Med Device Regs: A Dive into Guidelines — Medical Software Course

How are AI/ML medical devices regulated in Singapore? In this lesson, we take a detailed look at the Health Sciences Authority's (HSA) regulatory guidelines for software medical devices, focusing specifically on artificial intelligence and machine learning applications. We'll explore the unique requirements for pre-market submissions, delve into considerations for continuously learning systems, and understand the critical aspects of post-market monitoring to ensure safety and effectiveness.🎯 Learning Objectives• Understand Singapore's regulatory framework for AI/ML medical devices.• Identify key pre-market submission requirements for AI-MDs, including dataset and model documentation.• Explain considerations for continuously learning AI/ML systems, such as bias prevention and rollback capabilities.• Describe the importance of post-market monitoring for AI/ML medical devices to prevent performance drift.• Recognize the challenges and future outlook for regulating AI/ML in medical software. Learn more about your ad choices. Visit megaphone.fm/adchoices