USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
New EU Regulations on AI in Medical Devices: Key Insights and Implications
IMDRF Guidance: Good Machine Learning Practice for Medical Device Development: Guiding Principles
UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme