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Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
  • Author : Stephen F. Amato
  • Publsiher : Elsevier
  • Release : 27 October 2014
  • ISBN : 0857099205
  • Pages : 202 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKRegulatory Affairs for Biomaterials and Medical Devices

Summary:
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


Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
  • Author : Stephen F. Amato,Robert M. Ezzell Jr
  • Publisher : Elsevier
  • Release : 27 October 2014
GET THIS BOOKRegulatory Affairs for Biomaterials and Medical Devices

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

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Biomaterials and Medical Device - Associated Infections

Biomaterials and Medical Device - Associated Infections
  • Author : L Barnes,Ian Cooper
  • Publisher : Elsevier
  • Release : 21 November 2014
GET THIS BOOKBiomaterials and Medical Device - Associated Infections

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

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Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
  • Author : Jack Wong,Raymond Tong
  • Publisher : CRC Press
  • Release : 28 March 2018
GET THIS BOOKHandbook of Medical Device Regulatory Affairs in Asia

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

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Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Release : 21 November 2019
GET THIS BOOKBiocompatibility and Performance of Medical Devices

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

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Materials for Medical Application

Materials for Medical Application
  • Author : Robert B. Heimann
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release : 24 August 2020
GET THIS BOOKMaterials for Medical Application

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.

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Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release : 18 August 2015
GET THIS BOOKMedical Devices

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

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In Situ Tissue Regeneration

In Situ Tissue Regeneration
  • Author : Sang Jin Lee,Anthony Atala,James J Yoo
  • Publisher : Academic Press
  • Release : 17 July 2016
GET THIS BOOKIn Situ Tissue Regeneration

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

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Thin Film Coatings for Biomaterials and Biomedical Applications

Thin Film Coatings for Biomaterials and Biomedical Applications
  • Author : Hans J Griesser
  • Publisher : Woodhead Publishing
  • Release : 19 February 2016
GET THIS BOOKThin Film Coatings for Biomaterials and Biomedical Applications

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

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New Functional Biomaterials for Medicine and Healthcare

New Functional Biomaterials for Medicine and Healthcare
  • Author : Elena P. Ivanova,Kateryna Bazaka,Roy J. Crawford
  • Publisher : Woodhead Publishing
  • Release : 13 February 2014
GET THIS BOOKNew Functional Biomaterials for Medicine and Healthcare

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

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Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices
  • Author : J Pan
  • Publisher : Elsevier
  • Release : 24 October 2014
GET THIS BOOKModelling Degradation of Bioresorbable Polymeric Medical Devices

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

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Biomineralization and Biomaterials

Biomineralization and Biomaterials
  • Author : Conrado Aparicio,Maria Pau Ginebra
  • Publisher : Woodhead Publishing
  • Release : 28 September 2015
GET THIS BOOKBiomineralization and Biomaterials

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

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Science and Principles of Biodegradable and Bioresorbable Medical Polymers

Science and Principles of Biodegradable and Bioresorbable Medical Polymers
  • Author : Xiang Cheng Zhang
  • Publisher : Woodhead Publishing
  • Release : 22 September 2016
GET THIS BOOKScience and Principles of Biodegradable and Bioresorbable Medical Polymers

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,

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Wound Healing Biomaterials - Volume 1

Wound Healing Biomaterials - Volume 1
  • Author : Magnus Ågren
  • Publisher : Woodhead Publishing
  • Release : 03 June 2016
GET THIS BOOKWound Healing Biomaterials - Volume 1

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

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Silk Biomaterials for Tissue Engineering and Regenerative Medicine

Silk Biomaterials for Tissue Engineering and Regenerative Medicine
  • Author : Subhas Kundu
  • Publisher : Elsevier
  • Release : 24 March 2014
GET THIS BOOKSilk Biomaterials for Tissue Engineering and Regenerative Medicine

Silk is increasingly being used as a biomaterial for tissue engineering applications, as well as sutures, due to its unique mechanical and chemical properties. Silk Biomaterials for Tissue Engineering and Regenerative Medicine discusses the properties of silk that make it useful for medical purposes and its applications in this area. Part one introduces silk biomaterials, discussing their fundamentals and how they are processed, and considering different types of silk biomaterials. Part two focuses on the properties and behavior of silk

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 11 November 2021
GET THIS BOOKSafety Risk Management for Medical Devices

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

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