Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI devices in clinical trials, AI-driven strategies for regulatory compliance medical devices, the role of data in AI governance, and machine learning (ML) best practices. As always, we hope the articles will provide guidance and resources for regional and global regulatory professionals. We thank the authors for their time and generosity in sharing their expertise and real-world knowledge and experience with the RAPS community.
A robust regulatory framework is essential for Al/ML-enabled medical devices to sustain a balance between innovation and the delivery of safe and effective products, write Akanksha Kulshreshtha and Medha Sateesh Bharadwaj in The global regulatory landscape for AI/ML-enabled medical devices. They focus on regulations for these medical devices in the US, EU, Canada, UK, Singapore, China, Hong Kong, Brazil, South Korea, and Australia and under the International Medical Device Regulators Forum (IMDRF)…
