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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

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia Book
Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Release : 2018-03-28
ISBN : 0429996772
Language : En, Es, Fr & De

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Book Description :

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.

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

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

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices Book
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Release : 2019-11-21
ISBN : 0081026447
Language : En, Es, Fr & De

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Book Description :

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

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

Medical Device Regulatory Practices

Medical Device Regulatory Practices Book
Author : Val Theisz
Publisher : CRC Press
Release : 2015-08-03
ISBN : 9814669113
Language : En, Es, Fr & De

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Book Description :

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Green Based Nanocomposite Materials and Applications

Green Based Nanocomposite Materials and Applications Book
Author : Felipe Avalos Belmontes,Francisco J. González,Miguel Ángel López-Manchado
Publisher : Springer Nature
Release : 2023-02-01
ISBN : 3031184289
Language : En, Es, Fr & De

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Book Description :

This book presents a review of preparation methods for environmentally friendly nanocomposite materials. It describes the combination of biodegradable and biocompatible polymer matrices with nanoparticles, leading to finished products preferably prepared by sustainable methods. The chapters also describe how the addition of synthetic or non-biodegradable particles can influence the properties of the final products. This book presents a general overview of the process from the preparation to the final applications of green nanocomposites. In addition, the book also details the trends, challenges, and prospects of this type of composites. The content can be divided into two sections. The first one presents a brief introduction about the importance of keeping the environment free of non-degradable pollutants. It also describes fundamentals, trends, and general applications of green materials. The second section focuses on the description of some of the green-based materials most used nowadays and other innovative materials, just like elastomers of natural origin. The book comprises the reintegration of these materials into the environment, followed by some biomedical, biological, and energy storage applications.

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

Science and Principles of Biodegradable and Bioresorbable Medical Polymers

Science and Principles of Biodegradable and Bioresorbable Medical Polymers Book
Author : Xiang Cheng Zhang
Publisher : Woodhead Publishing
Release : 2016-09-22
ISBN : 0081003935
Language : En, Es, Fr & De

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Book Description :

Science and Principles of Biodegradable and Bioresorbable Medical Polymers: Materials and Properties provides a practical guide to the use of biodegradable and bioresorbable polymers for study, research, and applications within medicine. Fundamentals of the basic principles and science behind the use of biodegradable polymers in advanced research and in medical and pharmaceutical applications are presented, as are important new concepts and principles covering materials, properties, and computer modeling, providing the reader with useful tools that will aid their own research, product design, and development. Supported by practical application examples, the scope and contents of the book provide researchers with an important reference and knowledge-based educational and training aid on the basics and fundamentals of these important medical polymers. Provides a practical guide to the fundamentals, synthesis, and processing of bioresorbable polymers in medicine Contains comprehensive coverage of material properties, including unique insights into modeling degradation Written by an eclectic mix of international authors with experience in academia and industry

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

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

Bioresorbable Polymers for Biomedical Applications

Bioresorbable Polymers for Biomedical Applications Book
Author : Giuseppe Perale,Jöns Hilborn
Publisher : Woodhead Publishing
Release : 2016-08-24
ISBN : 0081002661
Language : En, Es, Fr & De

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Book Description :

Bioresorbable Polymers for Biomedical Applications: From Fundamentals to Translational Medicine provides readers with an overview of bioresorbable polymeric materials in the biomedical field. A useful resource for materials scientists in industry and academia, offering information on the fundamentals and considerations, synthesis and processing, and the clinical and R and D applications of bioresorbable polymers for biomedical applications. Focuses on biomedical applications of bioresorbable polymers Features a comprehensive range of topics including fundamentals, synthesis, processing, and applications Provides balanced coverage of the field with contributions from academia and industry Includes clinical and R and D applications of bioresorbable polymers for biomedical applications

Nanocomposites for Musculoskeletal Tissue Regeneration

Nanocomposites for Musculoskeletal Tissue Regeneration Book
Author : Huinan Liu
Publisher : Woodhead Publishing
Release : 2016-02-23
ISBN : 178242475X
Language : En, Es, Fr & De

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Book Description :

Nanocomposites for Musculoskeletal Tissue Regeneration discusses the advanced biomaterials scientists are exploring for use as tools to mimic the structure of musculoskeletal tissues. Bone and other musculoskeletal tissues naturally have a nanocomposite structure, therefore nanocomposites are ideally suited as a material for replacing and regenerating these natural tissues. In addition, biological properties such as biointegration and the ability to tailor and dope the materials make them highly desirable for musculoskeletal tissue regeneration. Provides a comprehensive discussion on the design and advancements made in the use of nanocomposites for musculoskeletal tissue regeneration Presents an In-depth coverage of material properties Includes discussions on polymers, ceramics, and glass

Surface Modification of Magnesium and its Alloys for Biomedical Applications

Surface Modification of Magnesium and its Alloys for Biomedical Applications Book
Author : T.S.N. Sankara Narayanan,Il-Song Park,Min-Ho Lee
Publisher : Elsevier
Release : 2015-01-08
ISBN : 1782420827
Language : En, Es, Fr & De

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Book Description :

Surface modification of magnesium and its alloys for biomedical applications: Biological interactions, mechanical properties and testing, the first of two volumes, is an essential guide on the use of magnesium as a degradable implant material. Due to their excellent biocompatibility and biodegradability, magnesium based degradable implants provide a viable option for the permanent metallic implants. This volume focuses on the fundamental concepts of surface modification of magnesium, its biological interactions, mechanical properties and, in vitro and in vivo testing. The contents of volume 1 is organized and presented in three parts. Part 1 reviews the fundamental aspects of surface modification of magnesium, including surface design, opportunities, challenges and its role in revolutionizing biodegradable biomaterials. Part 2 addresses the biological and mechanical properties covering an in vivo approach to the bioabsorbable behavior of magnesium alloys, mechanical integrity and, the effects of amino acids and proteins on the performance of surface modified magnesium. Part 3 delves in to testing and characterization, exploring the biocompatibility and effects on fatigue life alongside the primary characteristics of surface modified magnesium. All chapters are written by experts, this two volume series provides systematic and thorough coverage of all major modification technologies and coating types of magnesium and its alloys for biomedical applications. Expert analysis of the fundamentals in surface modification of magnesium and its alloys for biomedical applications Includes biological interactions and mechanical properties Focuses on testing and characterisation, as well as biocompatibility

Material Tissue Interfacial Phenomena

Material Tissue Interfacial Phenomena Book
Author : Paulette Spencer,Anil Misra
Publisher : Woodhead Publishing
Release : 2016-09-30
ISBN : 0081003412
Language : En, Es, Fr & De

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Book Description :

Material-Tissue Interfacial Phenomena: Contributions from Dental and Craniofacial Reconstructions explores the material/tissue interfacial phenomena using dental and craniofacial reconstructions as a model system. As the mouth is a particularly caustic environment, the synthetic and/or bio-enabled materials used to repair damaged tissues and restore form, function, and esthetics to oral structures must resist a variety of physical, chemical, and mechanical challenges. These challenges are magnified at the interface between dissimilar structures such as the tooth/material interface. Interfacial reactions at the atomic, molecular, and nano-scales initiate the failure of materials used to repair, restore, and reconstruct dental and craniofacial tissues. Understanding the phenomena that lead to failure at the interface between dissimilar structures, such as synthetic materials and biologic tissues, is confounded by a variety of factors that are thoroughly discussed in this comprehensive book. Provides a specific focus on the oral environment Combines clinical views and basic science into a useful reference book Presents comprehensive coverage of material-interfacial phenomena within the oral environment

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

Medical Modelling

Medical Modelling Book
Author : Richard Bibb,Dominic Eggbeer,Abby Paterson
Publisher : Woodhead Publishing
Release : 2014-12-13
ISBN : 1782423133
Language : En, Es, Fr & De

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Book Description :

Medical modelling and the principles of medical imaging, Computer Aided Design (CAD) and Rapid Prototyping (also known as Additive Manufacturing and 3D Printing) are important techniques relating to various disciplines - from biomaterials engineering to surgery. Building on the success of the first edition, Medical Modelling: The application of Advanced Design and Rapid Prototyping techniques in medicine provides readers with a revised edition of the original text, along with key information on innovative imaging techniques, Rapid Prototyping technologies and case studies. Following an overview of medical imaging for Rapid Prototyping, the book goes on to discuss working with medical scan data and techniques for Rapid Prototyping. In this second edition there is an extensive section of peer-reviewed case studies, describing the practical applications of advanced design technologies in surgical, prosthetic, orthotic, dental and research applications. Covers the steps towards rapid prototyping, from conception (modelling) to manufacture (manufacture) Includes a comprehensive case studies section on the practical application of computer-aided design (CAD) and rapid prototyping (RP) Provides an insight into medical imaging for rapid prototyping and working with medical scan data