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Medical Device Technologies: A Systems Based Overview Using Engineering Standards, Second Edition, offers a detailed insight into the world of medical device technology. This book provides a unified approach to each device area, covering technical operation, clinical need, regulatory issues, and standards, as well as historical devices. It adopts a systems-based view, striking a balance between breadth and depth to give an accessible introduction to this field. Close ties are drawn between the design, the product, and the patient.
Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling, or biocompatibility issues and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. This systems approach enables the reader to quickly identify the relationships between devices.
This book covers current research, design issues, and engineering standards in the medical device industry. It includes three significant Food and Drug Administration (FDA) recall case studies that have impacted FDA medical device regulation. These case studies provide valuable insights into the regulatory landscape and the importance of adhering to engineering standards.
Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature. Eight laboratory experiments in both electrical and mechanical medical devices are explored, providing hands-on reinforcement of device concepts. These exercises and experiments help readers deepen their understanding of medical device technologies and apply theoretical knowledge in practical settings.
Medical Device Technologies: A Systems Based Overview Using Engineering Standards, Second Edition, is an essential resource for professionals in the medical device industry. It offers a comprehensive overview of medical device technology, covering technical, clinical, regulatory, and historical aspects. This book is ideal for engineers, researchers, clinicians, and regulatory professionals seeking to enhance their knowledge and skills in this field.
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