Medical Devices

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• Author : Vinny R. Sastri
• Publisher : Elsevier
• Release Date : 2010-03-05
• Total pages : 352
• ISBN : 9780815520283
• File Size : 23,9 Mb
• Total Download : 872
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Download Plastics in Medical Devices in PDF, Epub, and Kindle

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

• Author : Jean-Pierre Boutrand
• Publisher : Woodhead Publishing
• Release Date : 2019-11-21
• Total pages : 586
• ISBN : 9780081026441
• File Size : 16,5 Mb
• Total Download : 116
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Download Biocompatibility and Performance of Medical Devices in PDF, Epub, and Kindle

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

• Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
• Publisher : Woodhead Publishing
• Release Date : 2015-08-18
• Total pages : 256
• ISBN : 9780081002919
• File Size : 37,9 Mb
• Total Download : 570
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Download Medical Devices in PDF, Epub, and Kindle

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

• Author : Peter J Ogrodnik
• Publisher : Academic Press
• Release Date : 2012-12-17
• Total pages : 376
• ISBN : 9780123919434
• File Size : 39,8 Mb
• Total Download : 674
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Download Medical Device Design in PDF, Epub, and Kindle

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

• Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
• Publisher : National Academies Press
• Release Date : 2010-11-14
• Total pages : 322
• ISBN : 9780309156295
• File Size : 28,8 Mb
• Total Download : 507
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Download The Role of Human Factors in Home Health Care in PDF, Epub, and Kindle

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

• Author : Arnab Ray
• Publisher : Academic Press
• Release Date : 2021-11-09
• Total pages : 332
• ISBN : 9780128182635
• File Size : 28,6 Mb
• Total Download : 735
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Download Cybersecurity for Connected Medical Devices in PDF, Epub, and Kindle

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions

• Author : Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt
• Publisher : Academic Press
• Release Date : 2019-09-06
• Total pages : 280
• ISBN : 9780128156377
• File Size : 9,5 Mb
• Total Download : 554
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Download Wearable and Implantable Medical Devices in PDF, Epub, and Kindle

Wearable and Implantable Medical Devices: Applications and Challenges, Fourth Edition highlights the new aspects of wearable and implanted sensors technology in the healthcare sector and monitoring systems. The book's contributions include several interdisciplinary domains, such as wearable sensors, implanted sensors devices, Internet-of-Things (IoT), security, real-time medical healthcare monitoring, WIBSN design and data management, encryption, and decision-support systems. Contributions emphasize several topics, including real-world applications and the design and implementation of wearable devices. This book demonstrates that this new field has a brilliant future in applied healthcare research and in healthcare monitoring systems. Includes comprehensive information on wearable and implanted device technology, wearable and implanted sensors design, WIBSN requirements, WIBSN in monitoring systems and security concepts Highlights machine learning and computing in healthcare monitoring systems based on WIBSN Includes a multidisciplinary approach to different healthcare applications and their associated challenges based on wearable and implanted technologies

• Author : Gail D. Baura,Gail Baura
• Publisher : Academic Press
• Release Date : 2011-10-07
• Total pages : 529
• ISBN : 9780123749765
• File Size : 21,8 Mb
• Total Download : 975
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Download Medical Device Technologies in PDF, Epub, and Kindle

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. 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. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

• Author : Dennis Fitzpatrick
• Publisher : Elsevier
• Release Date : 2014-11-05
• Total pages : 194
• ISBN : 9780124165779
• File Size : 9,5 Mb
• Total Download : 265
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Download Implantable Electronic Medical Devices in PDF, Epub, and Kindle

Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation therapy devices, and much more. Implantable Electronic Medical Devices equips the reader with essential background knowledge on the application of existing medical devices as well as providing an introduction to the latest techniques being used. A catalogue of existing implantable electronic medical devices Up-to-date information on the design of implantable electronic medical devices Background information and reviews on the application and design of up-to-date implantable electronic medical devices

• Author : Sophie Lerouge,Anne Simmons
• Publisher : Elsevier
• Release Date : 2012-09-27
• Total pages : 352
• ISBN : 9780857096265
• File Size : 34,8 Mb
• Total Download : 964
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Download Sterilisation of Biomaterials and Medical Devices in PDF, Epub, and Kindle

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

• Author : Susan Onel,Karen M. Becker
• Publisher : Unknown
• Release Date : 2016-11
• Total pages : 1112
• ISBN : 1402427743
• File Size : 9,6 Mb
• Total Download : 932
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Download Medical Devices Law and Regulation Answer Book in PDF, Epub, and Kindle

This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

• Author : Sina Ebnesajjad
• Publisher : Elsevier Inc. Chapters
• Release Date : 2013-12-05
• Total pages : 368
• ISBN : 9780128076682
• File Size : 16,9 Mb
• Total Download : 363
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Download Handbook of Polymer Applications in Medicine and Medical Devices in PDF, Epub, and Kindle

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

• Author : Ying Deng,Wei Lv
• Publisher : Woodhead Publishing
• Release Date : 2016-10-24
• Total pages : 238
• ISBN : 9780081003985
• File Size : 30,6 Mb
• Total Download : 977
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Download Biofilms and Implantable Medical Devices in PDF, Epub, and Kindle

Biofilms and Implantable Medical Devices: Infection and Control explores the increasing use of permanent and semi-permanent implants and indwelling medical devices. As an understanding of the growth and impact of biofilm formation on these medical devices and biomaterials is vital for protecting the health of the human host, this book provides readers with a comprehensive treatise on biofilms and their relationship with medical devices, also reporting on infections and associated strategies for prevention. Provides useful information on the fundamentals of biofilm problems in medical devices Discusses biofilm problems in a range of medical devices Focuses on strategies for prevention of biofilm formation

• Author : Mitsuo Niinomi
• Publisher : Elsevier
• Release Date : 2010-03-31
• Total pages : 432
• ISBN : 9781845699246
• File Size : 15,9 Mb
• Total Download : 572
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Download Metals for Biomedical Devices in PDF, Epub, and Kindle

Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials. With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods including surface treatment and sterilisation Examines metal selection for biomedical devices considering biocompatibility of various metals Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear

• Author : Dr. Kunal Pal,Heinz-Bernhard Kraatz,Anwesha Khasnobish,Sandip Bag,Indranil Banerjee,Usha Kuruganti
• Publisher : Woodhead Publishing
• Release Date : 2019-06-15
• Total pages : 1006
• ISBN : 9780081024218
• File Size : 18,6 Mb
• Total Download : 121
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Download Bioelectronics and Medical Devices in PDF, Epub, and Kindle

Bioelectronics and Medical Devices: From Materials to Devices-Fabrication, Applications and Reliability reviews the latest research on electronic devices used in the healthcare sector, from materials, to applications, including biosensors, rehabilitation devices, drug delivery devices, and devices based on wireless technology. This information is presented from the unique interdisciplinary perspective of the editors and contributors, all with materials science, biomedical engineering, physics, and chemistry backgrounds. Each applicable chapter includes a discussion of these devices, from materials and fabrication, to reliability and technology applications. Case studies, future research directions and recommendations for additional readings are also included. The book addresses hot topics, such as the latest, state-of the-art biosensing devices that have the ability for early detection of life-threatening diseases, such as tuberculosis, HIV and cancer. It covers rehabilitation devices and advancements, such as the devices that could be utilized by advanced-stage ALS patients to improve their interactions with the environment. In addition, electronic controlled delivery systems are reviewed, including those that are based on artificial intelligences. Presents the latest topics, including MEMS-based fabrication of biomedical sensors, Internet of Things, certification of medical and drug delivery devices, and electrical safety considerations Presents the interdisciplinary perspective of materials scientists, biomedical engineers, physicists and chemists on biomedical electronic devices Features systematic coverage in each chapter, including recent advancements in the field, case studies, future research directions, and recommendations for additional readings

• Author : Fang Gang
• Publisher : Elsevier
• Release Date : 2020-09-01
• Total pages : 344
• ISBN : 9780128225547
• File Size : 25,6 Mb
• Total Download : 507
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Download Nanoparticles in Analytical and Medical Devices in PDF, Epub, and Kindle

Nanoparticles in Analytical and Medical Devices presents the latest information on the use of nanoparticles for a diverse range of analytical and medical applications. Covers basic principles, proper use of nanoparticles in analytical and medical applications, and recent progress in the field. This comprehensive reference helps readers grasp the full potential of nanoparticles in their analytical research or medical practice. Chapters on cutting-edge topics bring readers up to date on the latest research and usage of nanoparticles, and a chapter on commercially available devices that utilize nanoparticles guides readers in overcoming issues with marketing biodevices. Synthesizes nanoparticle conjugation and other critical methods Covers nanoparticles in analytical methods and real analytical devices currently used in the medical field Provides useful new information not covered in the current literature in chapters on surface chemical functionalization for bio-immobilization and nanoparticle production from natural sources

• Author : Ajay Padsalgikar
• Publisher : William Andrew
• Release Date : 2017-02-01
• Total pages : 196
• ISBN : 9780323371223
• File Size : 38,9 Mb
• Total Download : 276
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Download Plastics in Medical Devices for Cardiovascular Applications in PDF, Epub, and Kindle

Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application Presents a range of applications, including artificial valves, stents, and vascular grafts Explains which materials can be used for each application, and why each is appropriate, thus assisting in the design of better tools and processes

• Author : J Pan
• Publisher : Elsevier
• Release Date : 2014-10-24
• Total pages : 260
• ISBN : 9781782420255
• File Size : 52,8 Mb
• Total Download : 435
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Download Modelling Degradation of Bioresorbable Polymeric Medical Devices in PDF, Epub, and Kindle

The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices. The final set of chapters look at advances in modelling biodegradation of bioresorbable polymers. This book is an essential guide to those concerned with replacing tests and experiments with modelling. Provides a comprehensive mathematical framework for computer modelling of polymers and polymeric medical devices that can significantly reduce the number of experiments needed. Reviews the fundamental methods of modelling degradation, and applies these to particular materials including amorphous bioresorbable polyesters, semicrystalline biodegradable polyesters, and composite materials made of biodegradable polyesters and triclcium phosphates

• Author : Aakash Deep
• Publisher : Academic Press
• Release Date : 2022-01-13
• Total pages : 187
• ISBN : 9780323911276
• File Size : 42,7 Mb
• Total Download : 834
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Download Medical Device Regulations in PDF, Epub, and Kindle

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

• Author : Beth Ann Fiedler
• Publisher : Elsevier
• Release Date : 2016-09-12
• Total pages : 0
• ISBN : 012804179X
• File Size : 52,7 Mb
• Total Download : 330
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Download Managing Medical Devices within a Regulatory Framework in PDF, Epub, and Kindle

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.

• Author : Ashim K Mitra,Kishore Cholkar,Abhirup Mandal
• Publisher : William Andrew
• Release Date : 2017-02-13
• Total pages : 416
• ISBN : 9780323429979
• File Size : 52,5 Mb
• Total Download : 261
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Download Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices in PDF, Epub, and Kindle

Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices covers the modern micro and nanotechnologies used for diagnosis, drug delivery, and theranostics using micro, nano, and implantable systems. In-depth coverage of all aspects of disease treatment is included. In addition, the book covers cutting-edge research and technology that will help readers gain knowledge of novel approaches and their applications to improve drug/agent specificity for diagnosis and efficient disease treatment. It is a comprehensive guide for medical specialists, the pharmaceutical-industry, and academic researchers discussing the impact of nanotechnology on diagnosis, drug delivery, and theranostics. Gives readers working in immunology, drug delivery, and medicine a greater awareness on how novel nanotechnology orientated methods can help improve treatment Provides readers with backgrounds in nanotechnology, chemistry, and materials science an understanding on how nanotechnology is used in immunology and drug delivery Includes focused coverage of the use of nanodevices in diagnostics, therapeutics, and theranostics not offered by other books