Regulatory 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 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

Produk Detail:

  • Author : Stephen F. Amato
  • Publisher : Elsevier
  • Pages : 202 pages
  • ISBN : 0857099205
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKRegulatory Affairs for Biomaterials and Medical Devices

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

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
  • Author : Jack Wong,Raymond Tong Kaiyu
  • Publisher : CRC Press
  • Release : 27 March 2013
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. Handbook of Medical Device Regulatory Affairs in Asia covers

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

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

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release : 01 December 2015
GET THIS BOOKBiomaterials, Medical Devices, and Combination Products

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

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

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
  • Author : Marie Teixeira,Richard Bradley
  • Publisher : CRC Press
  • Release : 20 September 2002
GET THIS BOOKDesign Controls for the Medical Device Industry

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

Szycher's Dictionary of Biomaterials and Medical Devices

Szycher's Dictionary of Biomaterials and Medical Devices
  • Author : Michael Szycher
  • Publisher : CRC Press
  • Release : 23 February 1992
GET THIS BOOKSzycher's Dictionary of Biomaterials and Medical Devices

This dictionary contains thousands of definitions from various related disciplines and minimizes the need for several dictionaries. The book defines everything from AAMI (Association for the Advancement of Medical Instrumentation) to zymogen (proenzyme). The editor, an internationally recognized expert in the area of biomaterials, has combined knowledge from the fields of medicine, pharmacology, physiology, polymer chemistry, biochemistry, metallurgy, and organic chemistry.

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

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs
  • Author : John J. Tobin,Gary Walsh
  • Publisher : John Wiley & Sons
  • Release : 02 September 2008
GET THIS BOOKMedical Product Regulatory Affairs

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/

The Medical Device R&D Handbook

The Medical Device R&D Handbook
  • Author : Theodore R. Kucklick
  • Publisher : CRC Press
  • Release : 21 November 2005
GET THIS BOOKThe Medical Device R&D Handbook

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

Commercializing Successful Biomedical Technologies

Commercializing Successful Biomedical Technologies
  • Author : Shreefal S. Mehta
  • Publisher : Cambridge University Press
  • Release : 24 April 2008
GET THIS BOOKCommercializing Successful Biomedical Technologies

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

FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : David Mantus,Douglas J. Pisano
  • Publisher : CRC Press
  • Release : 28 February 2014
GET THIS BOOKFDA Regulatory Affairs

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

Medical Device Regulations

Medical Device Regulations
  • Author : Michael Cheng,World Health Organization
  • Publisher : World Health Organization
  • Release : 16 September 2003
GET THIS BOOKMedical Device Regulations

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

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 : National Academies Press
  • Release : 04 October 2010
GET THIS BOOKPublic Health Effectiveness of the FDA 510(k) Clearance Process

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.