Modern Medical Device Regulation: Volume 1: Reliability

This hardcover edition includes additional bonus material for institutional and collections. This volume examines contemporary medical device regulation through the lens of reliability and lifecycle governance, with particular emphasis on the Total Product Life Cycle (TPLC) framework and associated operational implications for healthcare delivery organizations. The first chapter describes the structure of lifecycle-based regulation across pre-market, quality management, and post-market phases illustrating how mature regulatory systems in the European Union, Japan, China, and the United States implement continuous oversight. Special attention is given to how reliability is defined, demonstrated, and sustained across lifecycle stages, and to the role of international standards and reference organizations in supporting regulatory alignment despite differences in legal form.The second chapter translates these regulatory and lifecycle principles into practical operational strategy for Clinical Engineering and Health Technology management (CE/HTM) programs. A structured reliability and maintenance strategy toolkit is presented to support a "right-sized" quality management system (QMS) within hospital environments. The framework integrates risk-based maintenance justification, data architecture and UDI traceability, supplier controls, and post-market reliability analytics aligned with FDA QMSR, ISO 13485, ISO 14971, and accreditation expectations. U.S.-focused reliability templates demonstrate how lifecycle and post-market requirements can be implemented through usable documentation, decision rules, and management review inputs. The chapters show how CE/HTM programs can function as reliability-driven contributors to post-market science, regulatory transparency, and continuous improvement without adopting manufacturer-scale QMS complexity. Read more