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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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
4 Artificial intelligence:
Characteristics, regulatory compliance, and legislation
Koen Cobbaert, MSc
27 Modernizing medical devices regulation for AI and ML: GHWP efforts
Abdullatif S. Al Watban, PhD
33 Regulatory update for SaMD and AI product approvals in China
Hamish King, LLB, RAC
43 Enabling the digital transformation of industry: The roles of AI, big data,
analytics, and related data ecosystem
Wael William Diab, MS, MBA
48 Synthetic data and the innovation, assessment, and regulation of AI
Puja Myles, MPH, PhD; Johan Ordish, MA; Richard Branson, MSc, MA
Upcoming in RF Quarterly