Regulatory Affairs for Biomaterials and Medical Devices PDF Download

Author: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Category : Technology & Engineering
Languages : en
Pages : 203

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Book Description
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

Author: Jeffrey O. Hollinger
Publisher: CRC Press
ISBN: 1135501912
Category : Medical
Languages : en
Pages : 462

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Book Description
Focusing on bone biology, Bone Tissue Engineering integrates basic sciences with tissue engineering. It includes contributions from world-renowned researchers and clinicians who discuss key topics such as different models and approaches to bone tissue engineering, as well as exciting clinical applications for patients. Divided into four sections, t

Author: C.W. Patrick
Publisher: Elsevier
ISBN: 0080532055
Category : Technology & Engineering
Languages : en
Pages : 717

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Book Description
Frontiers in Tissue Engineering is a carefully edited compilation of state-of-the-art contributions from an international authorship of experts in the diverse subjects that make up tissue engineering. A broad representation of the medical, scientific, industrial and regulatory community is detailed in the book. The work is an authoritative and comprehensive reference source for scientists and clinicians working in this emerging field. The book is divided into three parts: fundamentals and methods of tissue engineering, tissue engineering applied to specialised tissues, and tissue engineering applied to organs. The text offers many novel approaches, including a detailed coverage of cell-tissue interactions at cellular and molecular levels; cell-tissue surface, biochemical, and mechanical environments; biomaterials; engineering design; tissue-organ function; new approaches to tissue-organ regeneration and replacement of function; ethical considerations of tissue engineering; and government regulation of tissue-engineered products.

Author: Carrie Sussman
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781774444
Category : Medical
Languages : en
Pages : 786

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Book Description
Designed for health care professionals in multiple disciplines and clinical settings, this comprehensive, evidence-based wound care text provides basic and advanced information on wound healing and therapies and emphasizes clinical decision-making. The text integrates the latest scientific findings with principles of good wound care and provides a complete set of current, evidence-based practices. This edition features a new chapter on wound pain management and a chapter showing how to use negative pressure therapy on many types of hard-to-heal wounds. Technological advances covered include ultrasound for wound debridement, laser treatments, and a single-patient-use disposable device for delivering pulsed radio frequency.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author: Manuela E. Gomes
Publisher: Academic Press
ISBN: 0128016000
Category : Science
Languages : en
Pages : 471

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Book Description
Tendon Regeneration: Understanding Tissue Physiology and Development to Engineer Functional Substitutes is the first book to highlight the multi-disciplinary nature of this specialized field and the importance of collaboration between medical and engineering laboratories in the development of tissue-oriented products for tissue engineering and regenerative medicine (TERM) strategies. Beginning with a foundation in developmental biology, the book explores physiology, pathology, and surgical reconstruction, providing guidance on biological approaches that enhances tendon regeneration practices. Contributions from scientists, clinicians, and engineers who are the leading figures in their respective fields present recent findings in tendon stem cells, cell therapies, and scaffold treatments, as well as examples of pre-clinical models for translational therapies and a view of the future of the field. - Provides an overview of tendon biology, disease, and tissue engineering approaches - Presents modern, alternative approaches to developing functional tissue solutions discussed - Includes valuable information for those interested in tissue engineering, tissue regeneration, tissue physiology, and regenerative medicine - Explores physiology, pathology, and surgical reconstruction, building a natural progression that enhances tendon regeneration practices - Covers recent findings in tendon stem cells, cell therapies, and scaffold treatments, as well as examples of pre-clinical models for translational therapies and a view of the future of the field

Author: Deepak K. Kalaskar
Publisher: UCL Press
ISBN: 1910634379
Category : Medical
Languages : en
Pages : 491

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Book Description
Written by experts from London’s renowned Royal Free Hospital, Textbook of Plastic and Reconstructive Surgery offers a comprehensive overview of the vast topic of reconstructive plastic surgery and its various subspecialties for introductory plastic surgery and surgical science courses. The book comprises five sections covering the fundamental principles of plastic surgery, cancer, burns and trauma, paediatric plastic surgery and aesthetic surgery, and covers the breadth of knowledge that students need to further their career in this exciting field. Additional coverage of areas in which reconstructive surgery techniques are called upon includes abdominal wall reconstruction, ear reconstruction and genital reconstruction. A chapter on aesthetic surgery includes facial aesthetic surgery and blepharoplasty, aesthetic breast surgery, body contouring and the evolution of hair transplantation.The broad scope of this volume and attention to often neglected specialisms such as military plastic surgery make this a unique contribution to the field. Heavily illustrated throughout, Textbook of Plastic and Reconstructive Surgery is essential reading for anyone interested in furthering their knowledge of this exciting field. This book was produced as part of JISC's Institution as e-Textbook Publisher project. Find out more at https://www.jisc.ac.uk/rd/projects/institution-as-e-textbook-publisher

Author: Ashutosh Tiwari
Publisher: John Wiley & Sons
ISBN: 1118773683
Category : Technology & Engineering
Languages : en
Pages : 421

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Book Description
Offers a comprehensive and interdisciplinary view of cutting-edge research on advanced materials for healthcare technology and applications Advanced healthcare materials are attracting strong interest in fundamental as well as applied medical science and technology. This book summarizes the current state of knowledge in the field of advanced materials for functional therapeutics, point-of-care diagnostics, translational materials, and up-and-coming bioengineering devices. Advanced Healthcare Materials highlights the key features that enable the design of stimuli-responsive smart nanoparticles, novel biomaterials, and nano/micro devices for either diagnosis or therapy, or both, called theranostics. It also presents the latest advancements in healthcare materials and medical technology. The senior researchers from global knowledge centers have written topics including: State-of-the-art of biomaterials for human health Micro- and nanoparticles and their application in biosensors The role of immunoassays Stimuli-responsive smart nanoparticles Diagnosis and treatment of cancer Advanced materials for biomedical application and drug delivery Nanoparticles for diagnosis and/or treatment of Alzheimers disease Hierarchical modelling of elastic behavior of human dental tissue Biodegradable porous hydrogels Hydrogels in tissue engineering, drug delivery, and wound care Modified natural zeolites Supramolecular hydrogels based on cyclodextrin poly(pseudo)rotaxane Polyhydroxyalkanoate-based biomaterials Biomimetic molecularly imprinted polymers

Author: Kishor Kumar Sadasivuni
Publisher: Elsevier
ISBN: 0081009747
Category : Science
Languages : en
Pages : 546

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Book Description
Biopolymer Composites in Electronics examines the current state-of-the-art in the electronic application based on biopolymer composites. Covering the synthesis, dispersion of fillers, characterization and fabrication of the composite materials, the book will help materials scientists and engineers address the challenges posed by the increased use of biopolymeric materials in electronic applications. The influence of preparation techniques on the generation of micro, meso, and nanoscale fillers, and the effect of filler size and dispersion on various biopolymers are discussed in detail. Applications covered include sensors, actuators, optics, fuel cells, photovoltaics, dielectrics, electromagnetic shielding, piezoelectrics, flexible displays, and microwave absorbers. In addition, characterization techniques are discussed and compared, enabling scientists and engineers to make the correct choice of technique. This book is a 'one-stop' reference for researchers, covering the entire state-of-the-art in biopolymer electronics. Written by a collection of expert worldwide contributors from industry, academia, government, and private research institutions, it is an outstanding reference for researchers in the field of biopolymer composites for advanced technologies. - Enables researchers to keep up with the rapid development of biopolymer electronics, which offer light, flexible, and more cost-effective alternatives to conventional materials of solar cells, light-emitting diodes, and transistors - Includes thorough coverage of the physics and chemistry behind biopolymer composites, helping readers to become rapidly acquainted with the fiel - Provides in-depth information on the range of biopolymer applications in electronics, from printed flexible conductors and novel semiconductor components, to intelligent labels, large area displays, and solar panels

Author: William Murphy
Publisher: Springer
ISBN: 1493933051
Category : Technology & Engineering
Languages : en
Pages : 676

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Book Description
This book provides tabular and text data relating to normal and diseased tissue materials and materials used in medical devices. Comprehensive and practical for students, researchers, engineers, and practicing physicians who use implants, this book considers the materials aspects of both implantable materials and natural tissues and fluids. Examples of materials and topics covered include titanium, elastomers, degradable biomaterials, composites, scaffold materials for tissue engineering, dental implants, sterilization effects on material properties, metallic alloys, and much more. Each chapter author considers the intrinsic and interactive properties of biomaterials, as well as their appropriate applications and historical contexts. Now in an updated second edition, this book also contains two new chapters on the cornea and on vocal folds, as well as updated insights, data, and citations for several chapters.