Regulatory Affairs for Biomaterials and Medical Devices

Written By Stephen F. Amato
Regulatory Affairs for Biomaterials and Medical Devices
  • Publsiher : Elsevier
  • Release : 27 October 2014
  • ISBN : 0857099205
  • Pages : 202 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato which was release on 27 October 2014, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book 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

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 Date : 2014-10-27
  • Total pages : 202
  • ISBN : 0857099205
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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 ...

Biomaterials and Medical Device Associated Infections

Biomaterials and Medical Device   Associated Infections
  • Author : L Barnes,Ian Cooper
  • Publisher : Elsevier
  • Release Date : 2014-11-21
  • Total pages : 278
  • ISBN : 0857099205
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Summary : 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 ...

Materials for Medical Application

Materials for Medical Application
  • Author : Robert B. Heimann
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2020-08-24
  • Total pages : 637
  • ISBN : 0857099205
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Summary : 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
  • Author : Sang Jin Lee,Anthony Atala,James J Yoo
  • Publisher : Academic Press
  • Release Date : 2016-07-17
  • Total pages : 458
  • ISBN : 0857099205
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Summary : 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, ...

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release Date : 2015-08-18
  • Total pages : 256
  • ISBN : 0857099205
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Summary : 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 ...

Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices
  • Author : J Pan
  • Publisher : Elsevier
  • Release Date : 2014-10-24
  • Total pages : 260
  • ISBN : 0857099205
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Summary : 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 ...

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 Date : 2014-02-13
  • Total pages : 244
  • ISBN : 0857099205
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Summary : 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 ...

Biomaterials and Regenerative Medicine in Ophthalmology

Biomaterials and Regenerative Medicine in Ophthalmology
  • Author : Traian Chirila,Damien Harkin
  • Publisher : Woodhead Publishing
  • Release Date : 2016-04-23
  • Total pages : 502
  • ISBN : 0857099205
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Summary : 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 ...

Medical Polymers

Medical Polymers
  • Author : Anonim
  • Publisher : iSmithers Rapra Publishing
  • Release Date : 2003
  • Total pages : 198
  • ISBN : 0857099205
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Summary : Medical Polymers 2003, the third international conference devoted to the use of polymers in the medical industry was held in Dublin, Ireland. The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Medical Polymers 2003 brought together speakers and delegates ...

Wound Healing Biomaterials Volume 1

Wound Healing Biomaterials   Volume 1
  • Author : Magnus Ågren
  • Publisher : Woodhead Publishing
  • Release Date : 2016-06-03
  • Total pages : 318
  • ISBN : 0857099205
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Summary : 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 ...

Chitosan Based Biomaterials Volume 2

Chitosan Based Biomaterials Volume 2
  • Author : Jessica Amber Jennings,Joel David Bumgardner
  • Publisher : Woodhead Publishing
  • Release Date : 2016-09-28
  • Total pages : 296
  • ISBN : 0857099205
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Summary : 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 ...

FDA Regulation of Medical Devices Including the Status of Breast Implants

FDA Regulation of Medical Devices  Including the Status of Breast Implants
  • Author : United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations,United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs
  • Publisher : Unknown
  • Release Date : 1996
  • Total pages : 206
  • ISBN : 0857099205
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Summary : Download or read online FDA Regulation of Medical Devices Including the Status of Breast Implants written by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations,United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural ...

Medical Biosensors for Point of Care POC Applications

Medical Biosensors for Point of Care  POC  Applications
  • Author : Roger J Narayan
  • Publisher : Woodhead Publishing
  • Release Date : 2016-08-21
  • Total pages : 316
  • ISBN : 0857099205
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Summary : 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 ...

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 Date : 2016-09-22
  • Total pages : 476
  • ISBN : 0857099205
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Summary : 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 ...

Advances in Polyurethane Biomaterials

Advances in Polyurethane Biomaterials
  • Author : Stuart L. Cooper,Jianjun Guan
  • Publisher : Woodhead Publishing
  • Release Date : 2016-01-23
  • Total pages : 718
  • ISBN : 0857099205
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Summary : Advances in Polyurethane Biomaterials brings together a thorough review of advances in the properties and applications of polyurethanes for biomedical applications. The first set of chapters in the book provides an important overview of the fundamentals of this material with chapters on properties and processing methods for polyurethane. Further sections ...