Medical Device Regulatory Practices

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Medical Device Regulatory Practices

Val Theisz
Medical Device Regulatory Practices Book PDF

Author : Val Theisz
Publisher : CRC Press
Page : 590 pages
File Size : 47,9 Mb
Release : 2015-08-03
Category : Medical
ISBN : 9789814669115

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Medical Device Regulatory Practices by Val Theisz Pdf

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.

Medical Devices

Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Medical Devices Book PDF

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 55,7 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

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

Handbook of Medical Device Regulatory Affairs in Asia

Jack Wong,Raymond Tong
Handbook of Medical Device Regulatory Affairs in Asia Book PDF

Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Page : 494 pages
File Size : 55,5 Mb
Release : 2018-03-28
Category : Medical
ISBN : 9780429996764

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Pdf

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.

Handbook of Medical Device Regulatory Affairs in Asia

Jack Wong,Raymond Tong Kaiyu
Handbook of Medical Device Regulatory Affairs in Asia Book PDF

Author : Jack Wong,Raymond Tong Kaiyu
Publisher : CRC Press
Page : 618 pages
File Size : 46,6 Mb
Release : 2013-03-27
Category : Medical
ISBN : 9789814411219

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Kaiyu Pdf

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 Device Regulations

Michael Cheng,World Health Organization
Medical Device Regulations Book PDF

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 47,6 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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.

Managing Medical Devices within a Regulatory Framework

Beth Ann Fiedler
Managing Medical Devices within a Regulatory Framework Book PDF

Author : Beth Ann Fiedler
Publisher : Elsevier
Page : 0 pages
File Size : 40,6 Mb
Release : 2016-09-12
Category : Technology & Engineering
ISBN : 012804179X

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Managing Medical Devices within a Regulatory Framework by Beth Ann Fiedler Pdf

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Orlando Lopez
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations Book PDF

Author : Orlando Lopez
Publisher : CRC Press
Page : 268 pages
File Size : 52,7 Mb
Release : 2016-11-03
Category : Business & Economics
ISBN : 9781315349978

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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations by Orlando Lopez Pdf

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

Medical Devices Law and Regulation Answer Book

Susan Onel,Karen M. Becker
Medical Devices Law and Regulation Answer Book Book PDF

Author : Susan Onel,Karen M. Becker
Publisher : Unknown
Page : 1112 pages
File Size : 46,8 Mb
Release : 2016-11
Category : Medical instruments and apparatus
ISBN : 1402427743

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Medical Devices Law and Regulation Answer Book by Susan Onel,Karen M. Becker Pdf

This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

Medical Regulatory Affairs

Jack Wong,Raymond K. Y. Tong
Medical Regulatory Affairs Book PDF

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 806 pages
File Size : 44,5 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440515

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

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. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Handbook of Medical Device Regulatory Affairs in Asia

Jack Wong,Raymond Tong
Handbook of Medical Device Regulatory Affairs in Asia Book PDF

Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Page : 620 pages
File Size : 52,6 Mb
Release : 2018-03-28
Category : Medical
ISBN : 9780429996771

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Pdf

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.

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

Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Public Health Effectiveness of the FDA 510 k Clearance Process Book PDF

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
Page : 141 pages
File Size : 49,9 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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.

Medical Device Regulations

Aakash Deep
Medical Device Regulations Book PDF

Author : Aakash Deep
Publisher : Academic Press
Page : 187 pages
File Size : 50,8 Mb
Release : 2022-01-13
Category : Technology & Engineering
ISBN : 9780323911276

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Medical Device Regulations by Aakash Deep Pdf

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Reliable Design of Medical Devices

Richard C. Fries
Reliable Design of Medical Devices Book PDF

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 53,7 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Medical Product Regulatory Affairs

John J. Tobin,Gary Walsh
Medical Product Regulatory Affairs Book PDF

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 304 pages
File Size : 44,9 Mb
Release : 2011-08-24
Category : Science
ISBN : 9783527644711

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

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.

Managing Medical Devices within a Regulatory Framework

Beth Ann Fiedler
Managing Medical Devices within a Regulatory Framework Book PDF

Author : Beth Ann Fiedler
Publisher : Elsevier
Page : 380 pages
File Size : 51,9 Mb
Release : 2016-09-10
Category : Technology & Engineering
ISBN : 9780128041925

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Managing Medical Devices within a Regulatory Framework by Beth Ann Fiedler Pdf

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices