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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
A NEW Member Benefit for 2021
Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role artificial intelligence (AI) in healthcare, its impact on global regulatory practice, and efforts to address challenges such as harmononization and standardization, bias, generalizability, and others.
1 Introduction: Artificial intelligence in global regulatory practice Renée Matthews HTML 4 Artificial intelligence: Characteristics, regulatory compliance, and legislation Koen Cobbaert, MSc HTML 27 Modernizing medical devices regulation for AI and ML: GHWP efforts Abdullatif S. Al Watban, PhD HTML 33 Regulatory update for SaMD and AI product approvals in China Hamish King, LLB, RAC HTML 43 Enabling the digital transformation of industry: The roles of AI, big data, analytics, and related data ecosystem Wael William Diab, MS, MBA HTML 48 Synthetic data and the innovation, assessment, and regulation of AI medical devices Puja Myles, MPH, PhD; Johan Ordish, MA; Richard Branson, MSc, MA HTML Upcoming in RF Quarterly