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 ...

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 ...

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 ...

Biosynthetic Polymers for Medical Applications

Biosynthetic Polymers for Medical Applications
  • Author : Laura Poole-Warren,Penny Martens,Rylie Green
  • Publisher : Elsevier
  • Release Date : 2015-11-23
  • Total pages : 358
  • ISBN : 0857099205
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Summary : 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 ...

Bioinspired Materials for Medical Applications

Bioinspired Materials for Medical Applications
  • Author : Lígia Rodrigues,Manuel Mota
  • Publisher : Woodhead Publishing
  • Release Date : 2016-09-24
  • Total pages : 544
  • ISBN : 0857099205
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Summary : 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 ...

Extracellular Matrix derived Implants in Clinical Medicine

Extracellular Matrix derived Implants in Clinical Medicine
  • Author : Daniel L Mooradian
  • Publisher : Woodhead Publishing
  • Release Date : 2016-05-18
  • Total pages : 202
  • ISBN : 0857099205
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Summary : 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 ...

Bioresorbable Polymers for Biomedical Applications

Bioresorbable Polymers for Biomedical Applications
  • Author : Giuseppe Perale,Jöns Hilborn
  • Publisher : Woodhead Publishing
  • Release Date : 2016-08-24
  • Total pages : 628
  • ISBN : 0857099205
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Summary : 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 ...

Biophotonics for Medical Applications

Biophotonics for Medical Applications
  • Author : Igor Meglinski
  • Publisher : Elsevier
  • Release Date : 2015-06-29
  • Total pages : 402
  • ISBN : 0857099205
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Summary : 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 ...

Nanocomposites for Musculoskeletal Tissue Regeneration

Nanocomposites for Musculoskeletal Tissue Regeneration
  • Author : Huinan Liu
  • Publisher : Woodhead Publishing
  • Release Date : 2016-02-23
  • Total pages : 406
  • ISBN : 0857099205
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Summary : 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, ...

Surface Modification of Magnesium and its Alloys for Biomedical Applications

Surface Modification of Magnesium and its Alloys for Biomedical Applications
  • Author : T.S.N. Sankara Narayanan,Il-Song Park,Min-Ho Lee
  • Publisher : Elsevier
  • Release Date : 2015-01-08
  • Total pages : 380
  • ISBN : 0857099205
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Summary : 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 ...

Material Tissue Interfacial Phenomena

Material Tissue Interfacial Phenomena
  • Author : Paulette Spencer,Anil Misra
  • Publisher : Woodhead Publishing
  • Release Date : 2016-09-30
  • Total pages : 382
  • ISBN : 0857099205
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Summary : 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 ...