Managing Medical Devices within a Regulatory Framework

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  • Publisher : Elsevier
  • Release : 10 September 2016
  • ISBN : 9780128041925
  • Page : 380 pages
  • Rating : 4.5/5 from 103 voters

Managing Medical Devices within a Regulatory Framework Book PDF 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 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

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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
  • ISBN : 9780128041925
DOWNLOAD BOOKManaging Medical Devices within a Regulatory Framework

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,

Managing Medical Devices Within a Regulatory Framework

Managing Medical Devices Within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release Date : 2016-09-01
  • ISBN : 012804179X
DOWNLOAD BOOKManaging Medical Devices Within a Regulatory Framework

"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,

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 Date : 2010-10-04
  • ISBN : 0309162904
DOWNLOAD 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.

Medical Devices

Medical Devices
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2010
  • ISBN : 9789241564045
DOWNLOAD BOOKMedical Devices

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

Medical Device Regulations

Medical Device Regulations
  • Author : Aakash Deep
  • Publisher : Academic Press
  • Release Date : 2022-01-13
  • ISBN : 9780323911276
DOWNLOAD BOOKMedical Device Regulations

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

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2017-05-09
  • ISBN : 9241512350
DOWNLOAD BOOKWHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation.

European Regulation of Medical Devices and Pharmaceuticals

European Regulation of Medical Devices and Pharmaceuticals
  • Author : Nupur Chowdhury
  • Publisher : Springer Science & Business
  • Release Date : 2014-04-29
  • ISBN : 9783319045948
DOWNLOAD BOOKEuropean Regulation of Medical Devices and Pharmaceuticals

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal

Medical Equipment Management

Medical Equipment Management
  • Author : Keith Willson,Keith Ison,Slavik Tabakov
  • Publisher : CRC Press
  • Release Date : 2013-12-07
  • ISBN : 9781420099591
DOWNLOAD BOOKMedical Equipment Management

Know What to Expect When Managing Medical Equipment and Healthcare Technology in Your Organization As medical technology in clinical care becomes more complex, clinical professionals and support staff must know how to keep patients safe and equipment working in the clinical environment. Accessible to all healthcare professionals and managers, Medical Equipment Management presents an integrated approach to managing medical equipment in healthcare organizations. The book explains the underlying principles and requirements and raises awareness of what needs to be done