Medical Device Design and Regulation

Description

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. Content: Front Matter • List of Figures and Tables • List of Abbreviations • Introduction • Table of Contents 1. Background and Regulatory Environment 2. Medical Device Design 3. Nonclinical Testing and GLPs 4. Clinical Trials 5. Marketing Applications 6. Post-Market Requirements 7. Quality Systems and GMPs 8. Compliance and Enforcement Appendices Index