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This book presents experts’ insights into the emerging technologies and developments that are being or will be utilized in the medical profession to meet a variety of clinical challenges. It demonstrates the application of biomechatronics to provide better care and service. It also incorporates new and exciting multidisciplinary areas of research across the medical and engineering fields, such as robotic therapeutic training system for stroke rehabilitation, exoskeletons for daily activities on persons with disability, functional electrical stimulation, and wireless active capsule endoscopy. Each chapter provides substantial background material relevant to the particular subject.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
This book explores the interconnection between geopolitical context and the ways this context frames our knowledge about Asia, highlighting previously neglected cause-effect relations. It also examines how various knowledge institutions promote and shape Asian Studies. The authors seek to explain why Asian Studies and its subfields developed in the way they did, and what the implications of these transformations might be on intellectual and political understandings of Asia. The book not only builds on the current debates on the decolonization and de-imperialization of knowledge about Asia; it also proposes a more multifaceted view rather than just examining the impact of the West on the framing of Asian Studies.
Wearable Technology in Medicine and Health Care provides readers with the most current research and information on the clinical and biomedical applications of wearable technology. Wearable devices provide applicability and convenience beyond many other means of technical interface and can include varying applications, such as personal entertainment, social communications and personalized health and fitness. The book covers the rapidly expanding development of wearable systems, thus enabling clinical and medical applications, such as disease management and rehabilitation. Final chapters discuss the challenges inherent to these rapidly evolving technologies. - Provides state-of-the-art coverag...
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Proceedings of the 15th International Conference on Applied Human Factors and Ergonomics and the Affiliated Conferences, Nice, France, 24-27 July 2024.
The ten-volume set LNCS 14220, 14221, 14222, 14223, 14224, 14225, 14226, 14227, 14228, and 14229 constitutes the refereed proceedings of the 26th International Conference on Medical Image Computing and Computer-Assisted Intervention, MICCAI 2023, which was held in Vancouver, Canada, in October 2023. The 730 revised full papers presented were carefully reviewed and selected from a total of 2250 submissions. The papers are organized in the following topical sections: Part I: Machine learning with limited supervision and machine learning – transfer learning; Part II: Machine learning – learning strategies; machine learning – explainability, bias, and uncertainty; Part III: Machine learnin...
This book explores the ways in which socio-technical settings in medical contexts find varying articulations in a specific locale. Focusing on Japan, it consists of nine case studies on topics concerning: experiences with radiation in Hiroshima, Nagasaki, and Fukushima; patient security, end-of-life and high-tech medicine in hospitals; innovation and diffusion of medical technology; and the engineering and evaluating of novel devices in clinical trials. The individual chapters situate humans and devices in medical settings in their given semantic, pragmatic, institutional and historical context. A highly interdisciplinary approach offers deep insights beyond the manifold findings of each case study, thereby enriching academic discussions on socio-technical settings in medical contexts amongst affiliated disciplines. This volume will be of broad interest to scholars, practitioners, policy makers and students from various disciplines, including Science and Technology Studies (STS), medical humanities, social sciences, ethics and law, business and innovation studies, as well as biomedical engineering, medicine and public health.
The eight-volume set LNCS 13431, 13432, 13433, 13434, 13435, 13436, 13437, and 13438 constitutes the refereed proceedings of the 25th International Conference on Medical Image Computing and Computer-Assisted Intervention, MICCAI 2022, which was held in Singapore in September 2022. The 574 revised full papers presented were carefully reviewed and selected from 1831 submissions in a double-blind review process. The papers are organized in the following topical sections: Part I: Brain development and atlases; DWI and tractography; functional brain networks; neuroimaging; heart and lung imaging; dermatology; Part II: Computational (integrative) pathology; computational anatomy and physiology; op...