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Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
  • Author : Stephen F. Amato,Robert M. Ezzell Jr
  • Publisher :Unknown
  • Release Date :2014-10-27
  • Total pages :202
  • ISBN : 9780857099204
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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 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 Kaiyu
  • Publisher :Unknown
  • Release Date :2013-03-27
  • Total pages :616
  • ISBN : 9789814411219
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Summary : 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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs
  • Author : John J. Tobin,Gary Walsh
  • Publisher :Unknown
  • Release Date :2011-08-24
  • Total pages :297
  • ISBN : 9783527644711
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Summary : Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Medical Device Regulatory Practices

Medical Device Regulatory Practices
  • Author : Val Theisz
  • Publisher :Unknown
  • Release Date :2015-08-03
  • Total pages :590
  • ISBN : 9789814669115
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Summary : 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.

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher :Unknown
  • Release Date :2019-11-21
  • Total pages :586
  • ISBN : 9780081026441
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Summary : 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

FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : Douglas J. Pisano,David S. Mantus
  • Publisher :Unknown
  • Release Date :2008-08-11
  • Total pages :464
  • ISBN : 1420073540
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Summary : Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher :Unknown
  • Release Date :2015-12-01
  • Total pages :606
  • ISBN : 9781482248388
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Summary : 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

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
  • Author : Marie Teixeira,Richard Bradley
  • Publisher :Unknown
  • Release Date :2002-09-20
  • Total pages :254
  • ISBN : 0203909380
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Summary : 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

Materials for Medical Application

Materials for Medical Application
  • Author : Robert B. Heimann
  • Publisher :Unknown
  • Release Date :2020-08-24
  • Total pages :637
  • ISBN : 9783110619249
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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.

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher :Unknown
  • Release Date :2015-08-18
  • Total pages :256
  • ISBN : 9780081002919
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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 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

Medical Device Design

Medical Device Design
  • Author : Peter J Ogrodnik
  • Publisher :Unknown
  • Release Date :2012-12-17
  • Total pages :376
  • ISBN : 9780123919434
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Summary : This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Medical Device Regulations

Medical Device Regulations
  • Author : Michael Cheng,World Health Organization
  • Publisher :Unknown
  • Release Date :2003-09-16
  • Total pages :43
  • ISBN : 9789241546188
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Summary : The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

The Medical Device R&D Handbook

The Medical Device R&D Handbook
  • Author : Theodore R. Kucklick
  • Publisher :Unknown
  • Release Date :2005-11-21
  • Total pages :376
  • ISBN : 9781420038354
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Summary : The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices
  • Author : Institute of Medicine,Board on Health Sciences Policy,Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
  • Publisher :Unknown
  • Release Date :2001-10-31
  • Total pages :112
  • ISBN : 0309183200
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Summary : The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Commercializing Successful Biomedical Technologies

Commercializing Successful Biomedical Technologies
  • Author : Shreefal S. Mehta
  • Publisher :Unknown
  • Release Date :2008-04-24
  • Total pages :229
  • ISBN : 9781107394216
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Summary : Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : David Mantus,Douglas J. Pisano
  • Publisher :Unknown
  • Release Date :2014-02-28
  • Total pages :400
  • ISBN : 9781841849201
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Summary : FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Publisher :Unknown
  • Release Date :2010-10-04
  • Total pages :140
  • ISBN : 0309162904
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Summary : The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Biotextiles as Medical Implants

Biotextiles as Medical Implants
  • Author : M W King,B S Gupta,R Guidoin
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :704
  • ISBN : 9780857095602
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Summary : Textiles play a vital role in the manufacture of various medical devices, including the replacement of diseased, injured or non-functioning organs within the body. Biotextiles as medical implants provides an invaluable single source of information on the main types of textile materials and products used for medical implants. The first part of the book focuses on polymers, fibers and textile technologies, and these chapters discuss the manufacture, sterilization, properties and types of biotextiles used for medical applications, including nanofibers, resorbable polymers and shaped biotextiles. The chapters in part two provide a comprehensive discussion of a range of different clinical applications of biotextiles, including surgical sutures, arterial prostheses, stent grafts, percutaneous heart valves and drug delivery systems. This book provides a concise review of the technologies, properties and types of biotextiles used as medical devices. In addition, it addresses the biological dimension of how to design devices for different clinical applications, providing an invaluable reference for biomedical engineers of medical textiles, quality control and risk assessment specialists, as well as managers of regulatory affairs. The subject matter will also be of interest to professionals within the healthcare system including surgeons, nurses, therapists, sourcing and purchasing agents, researchers and students in different disciplines. Provides an invaluable single source of information on the main types of textile materials and products used for medical implants Addresses the technologies used and discusses the manufacture, properties and types of biotextiles Examines applications of biotextiles as medical implants, including drug delivery systems and stent grafts and percutaneous heart valves

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation
  • Author : Institute of Medicine,Committee on Technological Innovation in Medicine
  • Publisher :Unknown
  • Release Date :1990-02-01
  • Total pages :244
  • ISBN : 9780309042864
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Summary : The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

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 : 0160522226
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Summary :

Biomaterials Science and Biocompatibility

Biomaterials Science and Biocompatibility
  • Author : Frederick H. Silver,David L. Christiansen
  • Publisher :Unknown
  • Release Date :2012-12-06
  • Total pages :342
  • ISBN : 9781461205579
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Summary : Adopting an interdisciplinary approach to the chemistry and physics of materials, their biocompatibility, and the consequences of implantation of such devices into the human body, this text introduces readers to the principles of polymer science and the study of metals, ceramics and composites, and also to the basic biology required to understand the nature of the host-transplant interface. Topics covered include the macromolecular components of cells and tissues, self-assembly processes, biological cascade systems, microscopic structure of cells and tissues, immunology, transplantation biology, and the pathobiology of wound healing. The materials science section includes the structures and properties of polymers, metals, ceramics and composites, and the processes for forming materials as well as the pathobiology of devices. The final two chapters deal with tissue engineering and the relations between the biology of cells and tissue transplantation, and the engineering of tissue replacements using passaged cells.