This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators' language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Overview of risk classification systems and regulatory controls for medical devices and IVDs in established markets and GHTF harmonization: definitions and basic terminology related to medical devices Core concepts of safety and effectiveness, use of standards, risk management, and clinical evaluation for medical devices Design History File (DHF) and technical documentation content and structure that satisfies requirements in all key markets: Summary Technical Documentation (STED) and Regulated Product Submission (RPS) Premarket design controls and an example of market access strategy template including regulatory strategy, clinical strategy, and reimbursement strategy Regulatory submissions and approvals in key markets Post-market regulatory controls including change management, post-market surveillance, performance of quality management systems, and regulatory systems and processes