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This article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of regulatory considerations in excipient selection and management, elucidating the complex landscape companies must navigate.

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations create overlapping audits and complex compliance pathways. The Medical Device Single Audit Program (MDSAP) and unique device identification (UDI) initiatives have advanced harmonization but remain limited by narrow scopes and database interoperability challenges. Quality management system (QMS) reforms in key markets highlight a growing emphasis on accelerating patient access. This article provides an overview of current quality trends, identifies persistent gaps, and offers a prognosis for future convergence.

This article examines the role of data protection and privacy laws in artificial intelligence (AI) development in healthcare across three regions: the US, EU, and Canada. It introduces key AI concepts and emphasizes the critical role of robust legal frameworks in safeguarding personal data. The analysis covers existing and proposed regulations, highlighting the interplay between data protection and general AI legal frameworks. It underscores the importance of understanding these evolving legal landscapes for AI developers navigating compliance challenges and market access strategies in an increasingly complex regulatory environment.

This article examines good machine learning practices (GMLPs) and highlights their application in the real-world setting as a way to improve transparency and explainability for medical device development.

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.

This article examines current initiatives and opportunities in the US and Canada to advance health equity in medical devices.

Welcome to the December issue of RF Quarterly, featuring selected presentations from the 2023 RAPS Convergence and including articles on pediatric drug development, the FDA's proposed ACNU rule, clinical evidence from a notary body perspective, submission content considerations for combination products, and attributes for successful regulatory leadership.