Managing Medical Devices within a Regulatory Framework

Written By Beth Ann Fiedler
Managing Medical Devices within a Regulatory Framework
  • Publsiher : Elsevier
  • Release : 10 September 2016
  • ISBN : 0128041927
  • Pages : 380 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler which was release on 10 September 2016, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: 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

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release Date : 2016-09-10
  • Total pages : 380
  • ISBN : 0128041927
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Summary : 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 ...

Medical Equipment Maintenance

Medical Equipment Maintenance
  • Author : Binseng Wang
  • Publisher : Morgan & Claypool Publishers
  • Release Date : 2012
  • Total pages : 71
  • ISBN : 0128041927
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Summary : In addition to being essential for safe and effective patient care, medical equipment also has significant impact on the income and, thus, vitality of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand ...

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants
  • Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
  • Publisher : Academic Press
  • Release Date : 2020-06-10
  • Total pages : 330
  • ISBN : 0128041927
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Summary : Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards ...

Blockchain Technology and Innovations in Business Processes

Blockchain Technology and Innovations in Business Processes
  • Author : Srikanta Patnaik
  • Publisher : Springer Nature
  • Release Date : 2021-05-15
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Download or read online Blockchain Technology and Innovations in Business Processes written by Srikanta Patnaik, published by Springer Nature which was released on . Get Blockchain Technology and Innovations in Business Processes Books now! Available in PDF, ePub and Kindle....

Medical Device Regulations

Medical Device Regulations
  • Author : Michael Cheng,World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2003-09-16
  • Total pages : 43
  • ISBN : 0128041927
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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 ...

WHO Drug Information

WHO Drug Information
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Download or read online WHO Drug Information written by , published by which was released on 2003. Get WHO Drug Information Books now! Available in PDF, ePub and Kindle....

Medical Equipment Maintenance Programme Overview

Medical Equipment Maintenance Programme Overview
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2012-08-01
  • Total pages : 92
  • ISBN : 0128041927
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Summary : WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy ...

Introduction to Medical Equipment Inventory Management

Introduction to Medical Equipment Inventory Management
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2012-10-25
  • Total pages : 30
  • ISBN : 0128041927
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Summary : WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy ...

Parliamentary Debates Hansard

Parliamentary Debates  Hansard
  • Author : Australia. Parliament. Senate
  • Publisher : Unknown
  • Release Date : 2002
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Download or read online Parliamentary Debates Hansard written by Australia. Parliament. Senate, published by which was released on 2002. Get Parliamentary Debates Hansard Books now! Available in PDF, ePub and Kindle....

Healthcare Financial Management

Healthcare Financial Management
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Download or read online Healthcare Financial Management written by , published by which was released on 2006. Get Healthcare Financial Management Books now! Available in PDF, ePub and Kindle....

Medical Technology Into Healthcare and Society

Medical Technology Into Healthcare and Society
  • Author : Alex Faulkner
  • Publisher : Health, Technology and Society
  • Release Date : 2009-01-15
  • Total pages : 238
  • ISBN : 0128041927
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Summary : Drawing from the sociology of medicine and from science and technology studies, the book develops new concepts to understand the changing patterns of control and promotion of medical technology, and its meaning in society. to explore new meanings of medicalisation and place evidence-based medicine in its policy context."--BOOK JACKET....

Health Care Technology Policy I

Health Care Technology Policy I
  • Author : Warren S. Grundfest
  • Publisher : Society of Photo Optical
  • Release Date : 1994
  • Total pages : 476
  • ISBN : 0128041927
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Summary : Download or read online Health Care Technology Policy I written by Warren S. Grundfest, published by Society of Photo Optical which was released on 1994. Get Health Care Technology Policy I Books now! Available in PDF, ePub and Kindle....

Development of Medical Device Policies

Development of Medical Device Policies
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2012-10-25
  • Total pages : 39
  • ISBN : 0128041927
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Summary : WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy ...

Health Professionals in Management

Health Professionals in Management
  • Author : Beaufort B. Longest
  • Publisher : McGraw-Hill/Appleton & Lange
  • Release Date : 1996
  • Total pages : 318
  • ISBN : 0128041927
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Summary : Download or read online Health Professionals in Management written by Beaufort B. Longest, published by McGraw-Hill/Appleton & Lange which was released on 1996. Get Health Professionals in Management Books now! Available in PDF, ePub and Kindle....

A Comparative Analysis of Medical Device Regulations in the EU and the USA

A Comparative Analysis of Medical Device Regulations in the EU and the USA
  • Author : Ann-Marie Jahn
  • Publisher : GRIN Verlag
  • Release Date : 2016-01-12
  • Total pages : 74
  • ISBN : 0128041927
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Summary : Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number ...