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Regulatory Affairs For Biomaterials And Medical Devices

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Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices Book
Author : Stephen F. Amato,Robert M. Ezzell Jr
Publisher : Elsevier
Release : 2014-10-27
ISBN : 0857099205
Language : En, Es, Fr & De

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Book Description :

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

Biomaterials and Medical Device Associated Infections

Biomaterials and Medical Device   Associated Infections Book
Author : L Barnes,Ian Cooper
Publisher : Elsevier
Release : 2014-11-21
ISBN : 0857097229
Language : En, Es, Fr & De

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Book Description :

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.

Materials for Medical Application

Materials for Medical Application Book
Author : Robert B. Heimann
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2020-08-24
ISBN : 3110619245
Language : En, Es, Fr & De

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Book Description :

This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.

In Situ Tissue Regeneration

In Situ Tissue Regeneration Book
Author : Sang Jin Lee,Anthony Atala,James J Yoo
Publisher : Academic Press
Release : 2016-07-17
ISBN : 012802500X
Language : En, Es, Fr & De

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Book Description :

In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design explores the body’s ability to mobilize endogenous stem cells to the site of injury and details the latest strategies developed for inducing and supporting the body’s own regenerating capacity. From the perspective of regenerative medicine and tissue engineering, this book describes the mechanism of host cell recruitment, cell sourcing, cellular and molecular roles in cell differentiation, navigational cues and niche signals, and a tissue-specific smart biomaterial system that can be applied to a wide range of therapies. The work is divided into four sections to provide a thorough overview and helpful hints for future discoveries: endogenous cell sources; biochemical and physical cues; smart biomaterial development; and applications. Explores the body’s ability to mobilize endogenous stem cells to the site of injury Details the latest strategies developed for inducing and supporting the body’s own regenerating capacity Presents smart biomaterials in cell-based tissue engineering applications—from the cell level to applications—in the first unified volume Features chapter authors and editors who are authorities in this emerging field Prioritizes a discussion of the future direction of smart biomaterials for in situ tissue regeneration, which will affect an emerging and lucrative industry

Medical Devices

Medical Devices Book
Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Release : 2015-08-18
ISBN : 0081002912
Language : En, Es, Fr & De

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Book Description :

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

Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices Book
Author : J Pan
Publisher : Elsevier
Release : 2014-10-24
ISBN : 1782420258
Language : En, Es, Fr & De

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Book Description :

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

Biomaterials and Regenerative Medicine in Ophthalmology

Biomaterials and Regenerative Medicine in Ophthalmology Book
Author : Traian Chirila,Damien Harkin
Publisher : Woodhead Publishing
Release : 2016-04-23
ISBN : 0081001843
Language : En, Es, Fr & De

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Book Description :

Biomaterials and Regenerative Medicine in Ophthalmology, Second Edition, focuses on an aging population and the increasing instances of eye diseases. Biomaterials continue to be used for numerous medical devices for the restoration of eyesight, improving many patients’ quality of life. Consequently, biomaterials and regenerative medicine are becoming increasingly important to the advances of ophthalmology and optometry. This book provides readers with an updated and expanded look at the present status and future direction of biomaterials and regenerative medicine in this important field. Provides an integral and significant exploration of biomaterials and regenerative medicine, presenting crucial advances made in the fields of ophthalmology and optometry, such as the development of intraocular lenses and new applications for contact lens Presents a new and updated look at the future direction of biomaterials and regenerative medicine in this field Comprehensive coverage in a range of fields, including hydrogels, corneal tissue engineering, and stem cell therapies for the restoration of the ocular surface

Wound Healing Biomaterials Volume 1

Wound Healing Biomaterials   Volume 1 Book
Author : Magnus Ågren
Publisher : Woodhead Publishing
Release : 2016-06-03
ISBN : 0081006055
Language : En, Es, Fr & De

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Book Description :

Wound Healing Biomaterials: Volume One, Therapies and Regeneration discusses the types of wounds associated with trauma, illness, or surgery that can sometimes be extremely complex and difficult to heal. Consequently, there is a prominent drive for scientists and clinicians to find methods to heal these types of wounds, with science increasingly turning towards biomaterials to address these challenges. Much research is now concerned with new therapies, regeneration methods, and biomaterials to assist in wound healing and healing response. This book provides readers with a comprehensive review of the fundamentals and advances in the field of wound healing with regard to therapies and tissue regeneration. Chapters in Part One discuss fundamentals and strategies of wound healing, while Part Two reviews gene, stem cell, and drug delivery therapies for wound healing. Final chapters look at tissue regeneration strategies, making this an all-encompassing book on the topic of wound care and biomaterials. Provides more systematic and comprehensive coverage of specific therapies and biomaterials for wound healing Highlights research that is concerned with new therapies, regeneration methods, and the use of biomaterials to assist in wound healing and healing response Presents an organized layout of the material that is carefully arranged with clear titles and comprehensive section headings Looks at tissue regeneration strategies, making this an all encompassing book on the topic of wound care

Chitosan Based Biomaterials Volume 2

Chitosan Based Biomaterials Volume 2 Book
Author : Jessica Amber Jennings,Joel David Bumgardner
Publisher : Woodhead Publishing
Release : 2016-09-28
ISBN : 0081002564
Language : En, Es, Fr & De

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Book Description :

Chitosan Based Biomaterials: Tissue Engineering and Therapeutics, Volume 2, provides the latest information on chitosan, a natural polymer derived from the marine material chitin. Chitosan displays unique properties, most notably biocompatibility and biodegradability. It can also be easily tuned to modify its structure or properties, making chitosan an excellent candidate as a biomaterial. Consequently, chitosan is being developed for many biomedical functions, ranging from tissue engineering and implant coatings to drug and gene delivery. This book provides readers with a full coverage of the applications of chitosan-based biomaterials. Presents specific focus on tissue engineering and therapeutics Provides comprehensive treatment of all biomaterial applications of chitosan Contains contributions by leading researchers with extensive experience in the material

Surface Coating and Modification of Metallic Biomaterials

Surface Coating and Modification of Metallic Biomaterials Book
Author : Cuie Wen
Publisher : Woodhead Publishing
Release : 2015-03-31
ISBN : 1782423168
Language : En, Es, Fr & De

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Book Description :

Despite advances in alternative materials, metals are still the biomaterial of choice for a number of clinical applications such as dental, orthopedic and cardiac implants. However, there are a number of intrinsic problems associated with implanting metal in the biological environment, such as wear, corrosion, biocompatibility and toxicity, which must be addressed. Modern technology has enabled scientists to modify metal surfaces or apply special coatings to metals to improve their performance safety. Surface Coating and Modification of Metallic Biomaterials will discuss the most important modification techniques and coatings for metals, first covering the fundamentals of metals as a biomaterial and then exploring surface modification techniques and coatings. An expansive overview of surface modification techniques for biomedical use In-depth exploration of issues arising from metal biomaterial use Includes examples of applications in a clinical setting

Medical Biosensors for Point of Care POC Applications

Medical Biosensors for Point of Care  POC  Applications Book
Author : Roger J Narayan
Publisher : Woodhead Publishing
Release : 2016-08-21
ISBN : 0081000782
Language : En, Es, Fr & De

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Book Description :

Medical Biosensors for Point of Care (POC) Applications discusses advances in this important and emerging field which has the potential to transform patient diagnosis and care. Part 1 covers the fundamentals of medical biosensors for point-of-care applications. Chapters in part 2 go on to look at materials and fabrication of medical biosensors while the next part looks at different technologies and operational techniques. The final set of chapters provide an overview of the current applications of this technology. Traditionally medical diagnostics have been dependent on sophisticated technologies which only trained professionals were able to operate. Recent research has focused on creating point-of-care diagnostic tools. These biosensors are miniaturised, portable, and are designed to be used at the point-of-care by untrained individuals, providing real-time and remote health monitoring. Provides essential knowledge for designers and manufacturers of biosensors for point-of-care applications Provides comprehensive coverage of the fundamentals, materials, technologies, and applications of medical biosensors for point-of-care applications Includes contributions from leading international researchers with extensive experience in developing medical biosensors Discusses advances in this important and emerging field which has the potential to transform patient diagnosis and care

Biomineralization and Biomaterials

Biomineralization and Biomaterials Book
Author : Conrado Aparicio,Maria Pau Ginebra
Publisher : Woodhead Publishing
Release : 2015-09-28
ISBN : 1782423567
Language : En, Es, Fr & De

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Book Description :

Biomineralization is a natural process by which living organisms form minerals in association with organic biostructures to form hybrid biological materials such as bone, enamel, dentine and nacre among others. Scientists have researched the fundamentals of these processes and the unique structures and properties of the resulting mineralized tissues. Inspired by them, new biomaterials for tissue engineering and regenerative medicine have been developed in recent years. Biomineralization and biomaterials: fundamentals and applications looks at the characteristics of these essential processes and natural materials and describes strategies and technologies to biomimetically design and produce biomaterials with improved biological performance. Provides a thorough overview of the biomineralization process Presents the most recent information on the natural process by which crystals in tissues form into inorganic structures such as bone, teeth, and other natural mineralized tissues Investigates methods for improving mineralization Explores new techniques that will help improve the biomimetic process

Functional Marine Biomaterials

Functional Marine Biomaterials Book
Author : Se-Kwon Kim
Publisher : Elsevier
Release : 2015-06-29
ISBN : 1782420940
Language : En, Es, Fr & De

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Book Description :

Functional Marine Biomaterials: Properties and Applications provides readers with the latest information on the diverse marine environment as a resource for many new substances, including biopolymers, bioceramics, and biominerals. As recent advances and funding has enabled scientists to begin harnessing many of these materials for biomedical applications from drug delivery to bone tissue engineering and biosensors, this important new text provides readers with a comprehensive review of these materials and their functional applications in the biomedical field. Chapters discuss the properties of the main classes of functional marine biomaterials, applications of marine products in tissue engineering, applications in drug delivery systems, and the role of marine derived materials in medical devices. Provides readers with the latest information on the diverse marine environment as a resource for many new substances, including biopolymers, bioceramics, and biominerals Presents a comprehensive review of these materials and their functional applications in the biomedical field Discusses the properties of the main classes of functional marine biomaterials, applications of marine products in tissue engineering, applications in drug delivery systems, and the role of marine derived materials in medical devices

Wound Healing Biomaterials Volume 2

Wound Healing Biomaterials   Volume 2 Book
Author : Magnus Ågren
Publisher : Woodhead Publishing
Release : 2016-05-30
ISBN : 0081006063
Language : En, Es, Fr & De

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Book Description :

Wound Healing Biomaterials: Volume Two, Functional Biomaterials discusses the types of wounds associated with trauma, illness, or surgery that can sometimes be extremely complex and difficult to heal. Consequently, there is a prominent drive for scientists and clinicians to find methods to heal wounds opening up a new area of research in biomaterials and the ways they can be applied to the challenges associated with wound care. Much research is now concerned with new therapies, regeneration methods, and the use of biomaterials that can assist in wound healing and alter healing responses. This book provides readers with a thorough review of the functional biomaterials used for wound healing, with chapters discussing the fundamentals of wound healing biomaterials, films for wound healing applications, polymer-based dressing for wound healing applications, and functional dressings for wound care. Includes more systematic and comprehensive coverage on the topic of wound care Provides thorough coverage of all specific therapies and biomaterials for wound healing Contains clear layout and organization that is carefully arranged with clear titles and comprehensive section headings Details specific sections on the fundamentals of wound healing biomaterials, films for wound healing applications, polymer-based dressing for wound healing applications, and more

Laser Surface Modification of Biomaterials

Laser Surface Modification of Biomaterials Book
Author : Rui Vilar
Publisher : Woodhead Publishing
Release : 2016-04-15
ISBN : 0081009429
Language : En, Es, Fr & De

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Book Description :

Laser Surface Modification of Biomaterials: Techniques and Applications covers this expanding field, which has many potential applications, including biomaterials. Laser surface modification of biomaterials enables the production of hybrid materials with different functionality in the bulk as well as the thin, sub-micrometer surface layer. This book will provide readers with a comprehensive review of the technology and its applications. Chapters in Part 1 look at the techniques and considerations of laser surface modification, while Part 2 reviews laser surface modification techniques of the most important classes of biomaterials, with a final set of chapters discussing application specific laser surface modification. Offers a comprehensive review of laser surface modification techniques Presents recent developments, fundamentals, and progress in laser surface modification Reviews laser surface modification applications across a range of materials Emphasizes applications in biomaterials

Biosynthetic Polymers for Medical Applications

Biosynthetic Polymers for Medical Applications Book
Author : Laura Poole-Warren,Penny Martens,Rylie Green
Publisher : Elsevier
Release : 2015-11-23
ISBN : 1782421130
Language : En, Es, Fr & De

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Book Description :

Biosynthetic Polymers for Medical Applications provides the latest information on biopolymers, the polymers that have been produced from living organisms and are biodegradable in nature. These advanced materials are becoming increasingly important for medical applications due to their favorable properties, such as degradability and biocompatibility. This important book provides readers with a thorough review of the fundamentals of biosynthetic polymers and their applications. Part One covers the fundamentals of biosynthetic polymers for medical applications, while Part Two explores biosynthetic polymer coatings and surface modification. Subsequent sections discuss biosynthetic polymers for tissue engineering applications and how to conduct polymers for medical applications. Comprehensively covers all major medical applications of biosynthetic polymers Provides an overview of non-degradable and biodegradable biosynthetic polymers and their medical uses Presents a specific focus on coatings and surface modifications, biosynthetic hydrogels, particulate systems for gene and drug delivery, and conjugated conducting polymers

Thin Film Coatings for Biomaterials and Biomedical Applications

Thin Film Coatings for Biomaterials and Biomedical Applications Book
Author : Hans J Griesser
Publisher : Woodhead Publishing
Release : 2016-02-19
ISBN : 1782424768
Language : En, Es, Fr & De

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Book Description :

Thin Film Coatings for Biomaterials and Biomedical Applications discusses the latest information on coatings, including their historic use by scientists who are looking to improve the properties and biological responses of the material-host interface. Thin films, in particular, are becoming more widely researched and used as an alternative to traditional sprayed coatings because they have a more uniform structure and therefore greater stability. This book provides readers with a comprehensive guide to thin film coatings and their application in the biomaterials field. Part One of the book details the fundamentals of thin films for biomedical application, while Part Two looks at the special properties of thin films, with a final section reviewing functional thin films and their usage in biomedical applications. Provides a comprehensive review on the fundamentals, properties, and functions of thin film coatings for biomaterials Covers a broad range of applications for implantable biomaterials Written by an international team of contributors who carefully tailor the presented information in a way that addresses industry needs

Bioinspired Materials for Medical Applications

Bioinspired Materials for Medical Applications Book
Author : Lígia Rodrigues,Manuel Mota
Publisher : Woodhead Publishing
Release : 2016-09-24
ISBN : 0081007469
Language : En, Es, Fr & De

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Book Description :

Bioinspired Materials for Medical Applications examines the inspiration of natural materials and their interpretation as modern biomaterials. With a strong focus on therapeutic and diagnostic applications, the book also examines the development and manipulation of bioinspired materials in regenerative medicine. The first set of chapters is heavily focused on bioinspired solutions for the delivery of drugs and therapeutics that also offer information on the fundamentals of these materials. Chapters in part two concentrate on bioinspired materials for diagnosis applications with a wide coverage of sensor and imaging systems With a broad coverage of the applications of bioinspired biomaterials, this book is a valuable resource for biomaterials researchers, clinicians, and scientists in academia and industry, and all those who wish to broaden their knowledge in the allied field. Explores how materials designed and produced with inspiration from nature can be used to enhance man-made biomaterials and medical devices Brings together the two fields of biomaterials and bioinspired materials Written by a world-class team of research scientists, engineers, and clinicians

Extracellular Matrix derived Implants in Clinical Medicine

Extracellular Matrix derived Implants in Clinical Medicine Book
Author : Daniel L Mooradian
Publisher : Woodhead Publishing
Release : 2016-05-18
ISBN : 008100219X
Language : En, Es, Fr & De

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Book Description :

Extracellular Matrix-Derived Implants in Clinical Medicine comprehensively covers the emergence of tissue engineering and regenerative medicine over the past few decades, along with discussions of continuous funding and research. The book provides a state-of-the-art review of this increasingly important technology and how it is translating from bench to bedside. Part One of the book looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological, while Part Two examines the challenges in harvesting, processing, and manufacturing of extracellular matrices, with a final section reviewing the international regulatory environment and economics of tissue-based products. Addresses issues of tissue engineering and regenerative medicine from a biomaterials industry perspective Looks at the historical use of human and animal tissues, focusing on the main application areas, including cardiovascular, hard and soft tissue engineering, and neurological Examines the challenges in harvesting, processing, and manufacturing of extracellular matrices Reviews the international regulatory environment and economics of tissue-based products

Biophotonics for Medical Applications

Biophotonics for Medical Applications Book
Author : Igor Meglinski
Publisher : Elsevier
Release : 2015-06-29
ISBN : 0857096745
Language : En, Es, Fr & De

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Book Description :

Biophotonics for Medical Applications presents information on the interface between laser optics and cell biology/medicine. The book discusses the development and application of photonic techniques that aid the diagnosis and therapeutics of biological tissues in both healthy and diseased states. Chapters cover the fundamental technologies used in biophotonics and a wide range of therapeutic and diagnostic applications. Presents information on the interface between laser optics and cell biology/medicine Discusses the development and application of photonic techniques which aid the diagnosis and therapeutics of biological tissues in both healthy and diseased states Presents the fundamental technologies used in biophotonics and a wide range of therapeutic and diagnostic applications