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

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

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.

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

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

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

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

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,

Medical Device Regulatory Practices

Medical Device Regulatory Practices
  • Author : Val Theisz
  • Publisher : CRC Press
  • Release : 03 August 2015
GET THIS BOOKMedical Device Regulatory Practices

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

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 : 08 January 2015
GET THIS BOOKSurface Modification of Magnesium and its Alloys for Biomedical Applications

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

Shoulder and Elbow Trauma and its Complications

Shoulder and Elbow Trauma and its Complications
  • Author : Michael Greiwe
  • Publisher : Woodhead Publishing
  • Release : 16 July 2015
GET THIS BOOKShoulder and Elbow Trauma and its Complications

Traumatic injuries to the shoulder remain a problem encountered by young and old alike. Trauma surgeons and shoulder and elbow specialists are called upon daily to improve the quality of life of injured individuals by restoring function, decreasing pain and returning individuals to their previous occupations and places in society. Such treatment provides both humanitarian and economic impact. Only recently have techniques and technology allowed surgeons to restore lives to such a degree following these injuries. Still, shoulder and elbow

Medical Biosensors for Point of Care (POC) Applications

Medical Biosensors for Point of Care (POC) Applications
  • Author : Roger J Narayan
  • Publisher : Woodhead Publishing
  • Release : 21 August 2016
GET THIS BOOKMedical Biosensors for Point of Care (POC) Applications

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

Biomedical Textiles for Orthopaedic and Surgical Applications

Biomedical Textiles for Orthopaedic and Surgical Applications
  • Author : Todd Blair
  • Publisher : Elsevier
  • Release : 13 March 2015
GET THIS BOOKBiomedical Textiles for Orthopaedic and Surgical Applications

Recent concerns over the possible effects of metal-on-metal orthopaedic implants and the evolution of more natural structures made from fibre have made medical device manufacturers consider the potential of fibre. Textiles offer the potential to replace traditional materials with novel fibres which are more suitable for many load bearing applications. Orthopaedics, in particular, is embracing textile technology for repairing, replacing, and regenerating integral pieces of the skeletal system and its associated components. This important new book will provide readers with

Surgical Techniques in Total Knee Arthroplasty and Alternative Procedures

Surgical Techniques in Total Knee Arthroplasty and Alternative Procedures
  • Author : Saverio Affatato
  • Publisher : Elsevier
  • Release : 09 December 2014
GET THIS BOOKSurgical Techniques in Total Knee Arthroplasty and Alternative Procedures

Total knee arthroplasty (TKA) is commonly considered to be a reliable procedure, with high implant survival rates at 10 to 15 years of follow-up. The goal of total knee replacement surgery is to relieve pain and obtain better knee function. This is achieved by ensuring correct patient selection, pre-operative deformity, implant design and accurate surgical techniques. This book covers a range of techniques for the realisation of functional joint motion and stability. The first part of the book will describe fundamentals in

Switchable and Responsive Surfaces and Materials for Biomedical Applications

Switchable and Responsive Surfaces and Materials for Biomedical Applications
  • Author : Johnathan Zhang
  • Publisher : Elsevier
  • Release : 11 December 2014
GET THIS BOOKSwitchable and Responsive Surfaces and Materials for Biomedical Applications

Surface modification of biomaterials can ultimately determine whether a material is accepted or rejected from the human body, and a responsive surface can further make the material "smart" and "intelligent". Switchable and Responsive Surfaces and Materials for Biomedical Applications outlines synthetic and biological materials that are responsive under different stimuli, their surface design and modification techniques, and applicability in regenerative medicine/tissue engineering, drug delivery, medical devices, and biomedical diagnostics. Part one provides a detailed overview of switchable and responsive