Yujan Shrestha

Articles by Yujan Shrestha

• Yujan’s RSNA Talk on AI/ML SaMD
• Yujan's Comments at FDA Digital Health Advisory Committee on GenAI Enabled Medical Devices
• 10x Coffee Talk: Generative AI and FDA Guidelines
• 10x Coffee Talk: Threat Modeling and Cybersecurity Risk Management
• FDA Grand Rounds on Synthetic Data
• Coffee Time: Medical Device Cybersecurity Threats
• Coffee Time: Is FDA Doing a Good Job with AI?
• AI Virtual Scribes: Premarket Performance Evaluation, Risk Management, and Postmarket Performance Monitoring
• FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond
• Open Source Radiology Foundation Models: A Comprehensive Exploration
• How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)
• How to Avoid 14 Common FDA Cybersecurity Deficiencies
• Foundation Models (LLM, LAM, LVM, LxM) and FDA Clearance: Best Practices, FAQs, and Presubmission Example
• 510(k) Preparation Pitfalls: Best Practices, FAQs, and Examples
• How to Write a Medical Device User Manual
• User Needs vs Requirements
• Future of Generative AI in Software Medical Devices
• AI/ML from Idea to FDA
• Algorithm Performance Testing Intake Form
• Webinar on AI/ML from Idea to FDA