Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
Author: Stephen F. Amato,Robert M. Ezzell Jr
Publsiher: Elsevier
Total Pages: 202
Release: 2014-10-27
ISBN 10: 0857099205
ISBN 13: 9780857099204
Language: EN, FR, DE, ES & NL

Regulatory Affairs for Biomaterials and Medical Devices Book Review:

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

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
Author: Jack Wong,Raymond Tong
Publsiher: CRC Press
Total Pages: 620
Release: 2018-03-28
ISBN 10: 0429996772
ISBN 13: 9780429996771
Language: EN, FR, DE, ES & NL

Handbook of Medical Device Regulatory Affairs in Asia Book Review:

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 countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Medical Device Regulatory Practices

Medical Device Regulatory Practices
Author: Val Theisz
Publsiher: CRC Press
Total Pages: 590
Release: 2015-08-03
ISBN 10: 9814669113
ISBN 13: 9789814669115
Language: EN, FR, DE, ES & NL

Medical Device Regulatory Practices Book Review:

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 regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Biomaterials and Medical Device Associated Infections

Biomaterials and Medical Device   Associated Infections
Author: L Barnes,Ian Cooper
Publsiher: Elsevier
Total Pages: 278
Release: 2014-11-21
ISBN 10: 0857097229
ISBN 13: 9780857097224
Language: EN, FR, DE, ES & NL

Biomaterials and Medical Device Associated Infections Book Review:

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 book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

Materials for Medical Application

Materials for Medical Application
Author: Robert B. Heimann
Publsiher: Walter de Gruyter GmbH & Co KG
Total Pages: 637
Release: 2020-08-24
ISBN 10: 3110619245
ISBN 13: 9783110619249
Language: EN, FR, DE, ES & NL

Materials for Medical Application Book Review:

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.

Medical Polymers

Medical Polymers
Author: Anonim
Publsiher: iSmithers Rapra Publishing
Total Pages: 198
Release: 2003
ISBN 10: 9781859573358
ISBN 13: 1859573355
Language: EN, FR, DE, ES & NL

Medical Polymers Book Review:

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 from the whole medical device supply chain to identify and address the challenges facing the industry. The conference began with a keynote presentation from the head of European and Regulatory Affairs at the Medical Devices Agency highlighting the many important regulatory issues now facing the industry. Following sessions covered new materials, latest product developments, compatibility of polymers, material advances, analysis and testing of medical polymers.

Materials for Medical Application

Materials for Medical Application
Author: Robert B. Heimann
Publsiher: Walter de Gruyter GmbH & Co KG
Total Pages: 637
Release: 2020-08-24
ISBN 10: 3110619318
ISBN 13: 9783110619317
Language: EN, FR, DE, ES & NL

Materials for Medical Application Book Review:

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.

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
Author: Jean-Pierre Boutrand
Publsiher: Woodhead Publishing
Total Pages: 586
Release: 2019-11-21
ISBN 10: 0081026447
ISBN 13: 9780081026441
Language: EN, FR, DE, ES & NL

Biocompatibility and Performance of Medical Devices Book Review:

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 the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

In Situ Tissue Regeneration

In Situ Tissue Regeneration
Author: Sang Jin Lee,Anthony Atala,James J Yoo
Publsiher: Academic Press
Total Pages: 458
Release: 2016-07-17
ISBN 10: 012802500X
ISBN 13: 9780128025000
Language: EN, FR, DE, ES & NL

In Situ Tissue Regeneration Book Review:

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 can be applied to a wide range of therapies. The work is divided into four sections to provide a thorough overview and helpful hints for future discoveries: endogenous cell sources; biochemical and physical cues; smart biomaterial development; and applications. Explores the body’s ability to mobilize endogenous stem cells to the site of injury Details the latest strategies developed for inducing and supporting the body’s own regenerating capacity Presents smart biomaterials in cell-based tissue engineering applications—from the cell level to applications—in the first unified volume Features chapter authors and editors who are authorities in this emerging field Prioritizes a discussion of the future direction of smart biomaterials for in situ tissue regeneration, which will affect an emerging and lucrative industry

Medical Devices

Medical Devices
Author: Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publsiher: Woodhead Publishing
Total Pages: 256
Release: 2015-08-18
ISBN 10: 0081002912
ISBN 13: 9780081002919
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

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 design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
Author: Marie Teixeira,Richard Bradley
Publsiher: CRC Press
Total Pages: 254
Release: 2002-09-20
ISBN 10: 9780203909386
ISBN 13: 0203909380
Language: EN, FR, DE, ES & NL

Design Controls for the Medical Device Industry Book Review:

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices
Author: J Pan
Publsiher: Elsevier
Total Pages: 260
Release: 2014-10-24
ISBN 10: 1782420258
ISBN 13: 9781782420255
Language: EN, FR, DE, ES & NL

Modelling Degradation of Bioresorbable Polymeric Medical Devices Book Review:

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 theories for bioresorbable polymers and devices. The final set of chapters look at advances in modelling biodegradation of bioresorbable polymers. This book is an essential guide to those concerned with replacing tests and experiments with modelling. Provides a comprehensive mathematical framework for computer modelling of polymers and polymeric medical devices that can significantly reduce the number of experiments needed. Reviews the fundamental methods of modelling degradation, and applies these to particular materials including amorphous bioresorbable polyesters, semicrystalline biodegradable polyesters, and composite materials made of biodegradable polyesters and triclcium phosphates

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
Publsiher: Unknown
Total Pages: 206
Release: 1996
ISBN 10: 1928374650XXX
ISBN 13: PURD:32754065311981
Language: EN, FR, DE, ES & NL

FDA Regulation of Medical Devices Including the Status of Breast Implants Book Review:

New Functional Biomaterials for Medicine and Healthcare

New Functional Biomaterials for Medicine and Healthcare
Author: Elena P. Ivanova,Kateryna Bazaka,Roy J. Crawford
Publsiher: Woodhead Publishing
Total Pages: 244
Release: 2014-02-13
ISBN 10: 1782422668
ISBN 13: 9781782422662
Language: EN, FR, DE, ES & NL

New Functional Biomaterials for Medicine and Healthcare Book Review:

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 synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics. Advances in processing technologies and our understanding of materials and their properties have made it possible for scientists and engineers to develop more sophisticated biomaterials with more targeted functionality. New Functional Biomaterials for Medicine and Healthcare provides an ideal one-volume summary of this important field that represents essential reading for scientists, engineers, and clinicians, and a useful reference text for undergraduate and postgraduate students. Provides a concise summary of the latest developments in key types of biomaterials Highlights key issues and challenges associated with the design of complex implantable systems Chapters focus on both natural and synthetic polymers, metallic biomaterials, and bio-inert and bioactive ceramics

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products
Author: Shayne Cox Gad,Samantha Gad-McDonald
Publsiher: CRC Press
Total Pages: 606
Release: 2015-12-01
ISBN 10: 1482248387
ISBN 13: 9781482248388
Language: EN, FR, DE, ES & NL

Biomaterials Medical Devices and Combination Products Book Review:

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Market Access in Global Biomedical Product Commercialization

Market Access in Global Biomedical Product Commercialization
Author: Steve Amato
Publsiher: Woodhead Publishing
Total Pages: 390
Release: 2015-10-31
ISBN 10: 9781782421146
ISBN 13: 1782421149
Language: EN, FR, DE, ES & NL

Market Access in Global Biomedical Product Commercialization Book Review:

In the past, life science product manufacturers were required to satisfy governmental regulatory requirements in their particular geographic area in order to receive commercialization access to that market. However, over the past ten years there has been a significant trend towards convergence of market access variables in the commercialization of life science products. Market access in global biomedical product commercialization discusses the commercialization and convergence of life science products, including medical devices, biomaterials, in vivo products and pharmaceuticals, from all global market access areas. Topics covered will include regulatory, reimbursement, pricing and health economic perspectives. Investigates the commercialization and convergence of life science products Strong focus on case studies, providing further insight into each topic Examines the differences between markets where the balance between private and public healthcare varies

Medical Devices

Medical Devices
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 129
Release: 2010
ISBN 10: 9241564040
ISBN 13: 9789241564045
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Wound Healing Biomaterials Volume 1

Wound Healing Biomaterials   Volume 1
Author: Magnus Ågren
Publsiher: Woodhead Publishing
Total Pages: 318
Release: 2016-06-03
ISBN 10: 0081006055
ISBN 13: 9780081006054
Language: EN, FR, DE, ES & NL

Wound Healing Biomaterials Volume 1 Book Review:

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 provides readers with a comprehensive review of the fundamentals and advances in the field of wound healing with regard to therapies and tissue regeneration. Chapters in Part One discuss fundamentals and strategies of wound healing, while Part Two reviews gene, stem cell, and drug delivery therapies for wound healing. Final chapters look at tissue regeneration strategies, making this an all-encompassing book on the topic of wound care and biomaterials. Provides more systematic and comprehensive coverage of specific therapies and biomaterials for wound healing Highlights research that is concerned with new therapies, regeneration methods, and the use of biomaterials to assist in wound healing and healing response Presents an organized layout of the material that is carefully arranged with clear titles and comprehensive section headings Looks at tissue regeneration strategies, making this an all encompassing book on the topic of wound care

Medical Biosensors for Point of Care POC Applications

Medical Biosensors for Point of Care  POC  Applications
Author: Roger J Narayan
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2016-08-21
ISBN 10: 0081000782
ISBN 13: 9780081000786
Language: EN, FR, DE, ES & NL

Medical Biosensors for Point of Care POC Applications Book Review:

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 been dependent on sophisticated technologies which only trained professionals were able to operate. Recent research has focused on creating point-of-care diagnostic tools. These biosensors are miniaturised, portable, and are designed to be used at the point-of-care by untrained individuals, providing real-time and remote health monitoring. Provides essential knowledge for designers and manufacturers of biosensors for point-of-care applications Provides comprehensive coverage of the fundamentals, materials, technologies, and applications of medical biosensors for point-of-care applications Includes contributions from leading international researchers with extensive experience in developing medical biosensors Discusses advances in this important and emerging field which has the potential to transform patient diagnosis and care

Science and Principles of Biodegradable and Bioresorbable Medical Polymers

Science and Principles of Biodegradable and Bioresorbable Medical Polymers
Author: Xiang Cheng Zhang
Publsiher: Woodhead Publishing
Total Pages: 476
Release: 2016-09-22
ISBN 10: 0081003935
ISBN 13: 9780081003930
Language: EN, FR, DE, ES & NL

Science and Principles of Biodegradable and Bioresorbable Medical Polymers Book Review:

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, product design, and development. Supported by practical application examples, the scope and contents of the book provide researchers with an important reference and knowledge-based educational and training aid on the basics and fundamentals of these important medical polymers. Provides a practical guide to the fundamentals, synthesis, and processing of bioresorbable polymers in medicine Contains comprehensive coverage of material properties, including unique insights into modeling degradation Written by an eclectic mix of international authors with experience in academia and industry