regulatory affairs for biomaterials and medical devices woodhead publishing series in biomaterials

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Regulatory Affairs For Biomaterials And Medical Devices

Author : Stephen F. Amato
ISBN : 9780857099204
Genre : Medical
File Size : 21. 32 MB
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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Biocompatibility And Performance Of Medical Devices

Author : Jean-Pierre Boutrand
ISBN : 9780857096456
Genre : Medical
File Size : 89. 96 MB
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Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Biomaterials And Medical Device Associated Infections

Author : L Barnes
ISBN : 9780857097224
Genre : Technology & Engineering
File Size : 50. 70 MB
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Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

Biomimetic Biomaterials

Author : Andrew J Ruys
ISBN : 9780857098887
Genre : Science
File Size : 54. 22 MB
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A significant proportion of modern medical technology has been developed through biomimetics, which is biologically inspired by studying pre-existing functioning systems in nature. Typical biomimetically inspired biomaterials include nano-biomaterials, smart biomaterials, hybrid biomaterials, nano-biocomposites, hierarchically porous biomaterials and tissue scaffolds. This important book summarises key research in this important field. The book is divided into two parts: Part one is devoted to the biomimetics of biomaterials themselves while part two provides overviews and case studies of tissue engineering applications from a biomimetics' perspective. The book has a strong focus on cutting edge biomimetically inspired biomaterials including chitin, hydrogels, calcium phosphates, biopolymers and anti-thrombotic coatings. Since many scaffolds for skin tissue engineering are biomimetically inspired, the book also has a strong focus on the biomimetics of tissue engineering in the repair of bone, skin, cartilage, soft tissue and specific organs. With its distinguished editor and international team of contributors, Biomimetic biomaterials is a standard reference for both the biomaterials research community and clinicians involved in such areas as bone regeneration, skin tissue and wound repair. Places strong focus on cutting edge biomimetically-inspired biomaterials including chitin, hydrogels, calcium phosphates, biopolymers and anti-thrombotic coatings Provides overviews and case studies of tissue engineering applications from a biomimetics perspective Also places focus on the biomimetics of tissue engineering in the repair of bone, skin, cartilage, soft tissue and specific organs

New Functional Biomaterials For Medicine And Healthcare

Author : Elena P. Ivanova
ISBN : 9781782422662
Genre : Technology & Engineering
File Size : 60. 9 MB
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New Functional Biomaterials for Medicine and Healthcare provides a concise summary of the latest developments in key types of biomaterials. The book begins with an overview of the use of biomaterials in contemporary healthcare and the process of developing novel biomaterials; the key issues and challenges associated with the design of complex implantable systems are also highlighted. The book then reviews the main materials used in functional biomaterials, particularly their properties and applications. Individual chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics. Advances in processing technologies and our understanding of materials and their properties have made it possible for scientists and engineers to develop more sophisticated biomaterials with more targeted functionality. New Functional Biomaterials for Medicine and Healthcare provides an ideal one-volume summary of this important field that represents essential reading for scientists, engineers, and clinicians, and a useful reference text for undergraduate and postgraduate students. Provides a concise summary of the latest developments in key types of biomaterials Highlights key issues and challenges associated with the design of complex implantable systems Chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics

Managing Medical Devices Within A Regulatory Framework

Author : Beth Ann Fiedler
ISBN : 9780128041925
Genre : Technology & Engineering
File Size : 49. 40 MB
Format : PDF
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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. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Biotextiles As Medical Implants

Author : M W King
ISBN : 9780857095602
Genre : Technology & Engineering
File Size : 30. 42 MB
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Textiles play a vital role in the manufacture of various medical devices, including the replacement of diseased, injured or non-functioning organs within the body. Biotextiles as medical implants provides an invaluable single source of information on the main types of textile materials and products used for medical implants. The first part of the book focuses on polymers, fibers and textile technologies, and these chapters discuss the manufacture, sterilization, properties and types of biotextiles used for medical applications, including nanofibers, resorbable polymers and shaped biotextiles. The chapters in part two provide a comprehensive discussion of a range of different clinical applications of biotextiles, including surgical sutures, arterial prostheses, stent grafts, percutaneous heart valves and drug delivery systems. This book provides a concise review of the technologies, properties and types of biotextiles used as medical devices. In addition, it addresses the biological dimension of how to design devices for different clinical applications, providing an invaluable reference for biomedical engineers of medical textiles, quality control and risk assessment specialists, as well as managers of regulatory affairs. The subject matter will also be of interest to professionals within the healthcare system including surgeons, nurses, therapists, sourcing and purchasing agents, researchers and students in different disciplines. Provides an invaluable single source of information on the main types of textile materials and products used for medical implants Addresses the technologies used and discusses the manufacture, properties and types of biotextiles Examines applications of biotextiles as medical implants, including drug delivery systems and stent grafts and percutaneous heart valves

Biomaterials And Medical Devices

Author : Ferdiansyah Mahyudin
ISBN : 9783319148458
Genre : Technology & Engineering
File Size : 44. 25 MB
Format : PDF
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This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.

Introduction To Biomaterials

Author : J. L. Ong
ISBN : 9780521116909
Genre : Medical
File Size : 67. 82 MB
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A succinct introduction to the field of biomaterials engineering, packed with practical insights.

Biomaterials And Their Applications

Author : Hamid Reza Rezaie
ISBN : 9783319178462
Genre : Technology & Engineering
File Size : 49. 42 MB
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This short book presents an overview of different types of biomaterial such as bio ceramics, bio polymers, metals and bio composites, while especially focusing on nano biomaterials and their applications in different tissues. It provides a compact introduction to nano materials for drug delivery systems, tissue engineering and implants, while also reviewing essential trends in the biomaterial field over the last few decades and the latest developments.

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