Modern Medical Device Regulation: Volume 2: Risk & Pre-Market Governance

Risk classification shapes every regulatory decision in modern medical device oversight. Market authorization, evidentiary thresholds, cybersecurity controls, AI governance, manufacturing accountability, and post-market obligations all originate in how risk is defined and stratified at the outset. Volume II: Risk & Pre-market Governance examines the structural relationships between risk classification and global market access. Drawing from FDA modernization, EU MDR implementation, IMDRF harmonization efforts, and Asia-Pacific authorization models, this volume demonstrates how classification architecture determines lifecycle governance requirements across jurisdictions. Key topics include: Global risk classification systems and IMDRF alignment The evolution from QSR to QMSR and harmonized ISO 13485 integration Design control and change management under lifecycle oversight AI/ML governance and predetermined change control plans (PCCPs) Cybersecurity as a statutory gate to U.S. market access Servicing, remanufacturing, and regulatory inflection points China and Japan authorization structures and manufacturing accountability End-of-life controls and environmental compliance integration Rather than treating pre-market review as a single regulatory milestone, this volume positions risk classification as the architectural foundation of total product lifecycle governance. Designed for regulatory professionals, quality leaders, manufacturers, clinical engineers, and policy scholars, Volume II advances a structured framework for navigating modern medical device regulation in an era defined by convergence, digital transformation, and intelligent systems.