Regulatory Compass: Your Guide to Medical Device Laws

This book provides a comprehensive and comparative overview of global medical device regulatory frameworks, with a focus on the European Union Medical Device Regulation (EU MDR), the United States Food and Drug Administration (FDA) system, and the regulatory environments of Pakistan and Morocco. 

Designed for students, engineers, innovators, and policy-oriented readers, the book explores the full lifecycle of medical devices from conception and design to market approval, post-market surveillance, and regulatory compliance. It examines risk classification systems, conformity assessment procedures, quality management standards, and the growing role of emerging technologies such as artificial intelligence and digital health in regulatory oversight.

By combining regulatory theory with practical examples and comparative analysis, this work aims to support a deeper understanding of how medical device regulations shape innovation, patient safety, and global market access.