Regulatory Affairs for Biomaterials and Medical Devices Book

Regulatory Affairs for Biomaterials and Medical Devices


  • Author : Stephen F. Amato
  • Publisher : Elsevier
  • Release Date : 2014-10-27
  • Genre: Medical
  • Pages : 202
  • ISBN 10 : 9780857099204

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Regulatory Affairs for Biomaterials and Medical Devices Excerpt :

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 Book

Handbook of Medical Device Regulatory Affairs in Asia


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Genre: Medical
  • Pages : 620
  • ISBN 10 : 9780429996771

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Handbook of Medical Device Regulatory Affairs in Asia Excerpt :

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.

Materials for Medical Application Book

Materials for Medical Application


  • Author : Robert B. Heimann
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2020-08-24
  • Genre: Science
  • Pages : 637
  • ISBN 10 : 9783110619249

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Materials for Medical Application Excerpt :

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 Book

In Situ Tissue Regeneration


  • Author : Sang Jin Lee
  • Publisher : Academic Press
  • Release Date : 2016-07-17
  • Genre: Medical
  • Pages : 458
  • ISBN 10 : 9780128025000

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In Situ Tissue Regeneration Excerpt :

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 Device Regulatory Practices Book

Medical Device Regulatory Practices


  • Author : Val Theisz
  • Publisher : CRC Press
  • Release Date : 2015-08-03
  • Genre: Medical
  • Pages : 590
  • ISBN 10 : 9789814669115

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Medical Device Regulatory Practices Excerpt :

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.

Biocompatibility and Performance of Medical Devices Book

Biocompatibility and Performance of Medical Devices


  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Release Date : 2019-11-21
  • Genre: Medical
  • Pages : 586
  • ISBN 10 : 9780081026441

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Biocompatibility and Performance of Medical Devices Excerpt :

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

Medical Devices Book

Medical Devices


  • Author : Seeram Ramakrishna
  • Publisher : Woodhead Publishing
  • Release Date : 2015-08-18
  • Genre: Medical
  • Pages : 256
  • ISBN 10 : 9780081002919

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Medical Devices Excerpt :

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

Safety Risk Management for Medical Devices Book

Safety Risk Management for Medical Devices


  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release Date : 2021-11-11
  • Genre: Technology & Engineering
  • Pages : 534
  • ISBN 10 : 9780323918237

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Safety Risk Management for Medical Devices Excerpt :

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Modelling Degradation of Bioresorbable Polymeric Medical Devices Book

Modelling Degradation of Bioresorbable Polymeric Medical Devices


  • Author : J Pan
  • Publisher : Elsevier
  • Release Date : 2014-10-24
  • Genre: Technology & Engineering
  • Pages : 260
  • ISBN 10 : 9781782420255

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Modelling Degradation of Bioresorbable Polymeric Medical Devices Excerpt :

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 Biosensors for Point of Care  POC  Applications Book

Medical Biosensors for Point of Care POC Applications


  • Author : Roger J Narayan
  • Publisher : Woodhead Publishing
  • Release Date : 2016-08-21
  • Genre: Medical
  • Pages : 316
  • ISBN 10 : 9780081000786

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Medical Biosensors for Point of Care POC Applications Excerpt :

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 Book

Science and Principles of Biodegradable and Bioresorbable Medical Polymers


  • Author : Xiang Cheng Zhang
  • Publisher : Woodhead Publishing
  • Release Date : 2016-09-22
  • Genre: Medical
  • Pages : 476
  • ISBN 10 : 9780081003930

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Science and Principles of Biodegradable and Bioresorbable Medical Polymers Excerpt :

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 Book

Biosynthetic Polymers for Medical Applications


  • Author : Laura Poole-Warren
  • Publisher : Elsevier
  • Release Date : 2015-11-23
  • Genre: Medical
  • Pages : 358
  • ISBN 10 : 9781782421139

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Biosynthetic Polymers for Medical Applications Excerpt :

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 Book

Bioinspired Materials for Medical Applications


  • Author : Lígia Rodrigues
  • Publisher : Woodhead Publishing
  • Release Date : 2016-09-24
  • Genre: Technology & Engineering
  • Pages : 544
  • ISBN 10 : 9780081007464

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Bioinspired Materials for Medical Applications Excerpt :

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 Book

Extracellular Matrix derived Implants in Clinical Medicine


  • Author : Daniel L Mooradian
  • Publisher : Woodhead Publishing
  • Release Date : 2016-05-18
  • Genre: Technology & Engineering
  • Pages : 202
  • ISBN 10 : 9780081002193

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Extracellular Matrix derived Implants in Clinical Medicine Excerpt :

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 Book

Bioresorbable Polymers for Biomedical Applications


  • Author : Giuseppe Perale
  • Publisher : Woodhead Publishing
  • Release Date : 2016-08-24
  • Genre: Technology & Engineering
  • Pages : 628
  • ISBN 10 : 9780081002667

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Bioresorbable Polymers for Biomedical Applications Excerpt :

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