Managing Medical Devices Within a Regulatory Framework Book

Managing Medical Devices Within a Regulatory Framework


  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release Date : 2016-09-01
  • Genre: Uncategoriezed
  • Pages : 392
  • ISBN 10 : 012804179X

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Managing Medical Devices Within a Regulatory Framework 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 devicesProvides operational and clinical practice recommendations in regard to regulatory changes for risk managementDiscusses best practices for equipment procurement and maintenanceProvides 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 Book

Managing Medical Devices within a Regulatory Framework


  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release Date : 2016-09-10
  • Genre: Technology & Engineering
  • Pages : 380
  • ISBN 10 : 9780128041925

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Managing Medical Devices within a Regulatory Framework 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

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

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
  • Genre: Law
  • Pages : 72
  • ISBN 10 : 9241512350

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

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. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4

Public Health Effectiveness of the FDA 510 k  Clearance Process Book

Public Health Effectiveness of the FDA 510 k Clearance Process


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2010-10-04
  • Genre: Medical
  • Pages : 140
  • ISBN 10 : 0309162904

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Public Health Effectiveness of the FDA 510 k Clearance Process Excerpt :

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 Book

Medical Device Regulations


  • Author : Aakash Deep
  • Publisher : Academic Press
  • Release Date : 2022-01-13
  • Genre: Technology & Engineering
  • Pages : 187
  • ISBN 10 : 9780323911276

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Medical Device Regulations Excerpt :

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

Handbook of Medical Device Regulatory Affairs in Asia Book

Handbook of Medical Device Regulatory Affairs in Asia


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Genre: Medical
  • Pages : 620
  • ISBN 10 : 9780429996771

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Handbook of Medical Device Regulatory Affairs in Asia Excerpt :

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.

Medical Equipment Management Book

Medical Equipment Management


  • Author : Keith Willson
  • Publisher : CRC Press
  • Release Date : 2013-12-07
  • Genre: Medical
  • Pages : 344
  • ISBN 10 : 9781420099591

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Medical Equipment Management Excerpt :

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 and what questions to ask. It also provides practical advice and refers readers to appropriate legislation and guidelines. Starting from the medical equipment lifecycle, the book takes a risk-based approach to improving the way in which medical devices are acquired and managed in a clinical context. Drawing on their extensive managerial and teaching experiences, the authors explain how organizational structures and policies are set up, how funding is allocated, how people and equipment are supported, and what to do when things go wrong.

Innovation and Protection Book

Innovation and Protection


  • Author : I. Glenn Cohen
  • Publisher : Cambridge University Press
  • Release Date : 2022-04-07
  • Genre: Law
  • Pages : 295
  • ISBN 10 : 9781108838634

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Innovation and Protection Excerpt :

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

European Regulation of Medical Devices and Pharmaceuticals Book

European Regulation of Medical Devices and Pharmaceuticals


  • Author : Nupur Chowdhury
  • Publisher : Springer Science & Business
  • Release Date : 2014-04-29
  • Genre: Law
  • Pages : 185
  • ISBN 10 : 9783319045948

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European Regulation of Medical Devices and Pharmaceuticals Excerpt :

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 order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulatio

Medical Regulatory Affairs Book

Medical Regulatory Affairs


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2022-01-27
  • Genre: Medical
  • Pages : 806
  • ISBN 10 : 9781000440515

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Medical Regulatory Affairs Excerpt :

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.

Medical Device Regulations Book
Score: 4
From 1 Ratings

Medical Device Regulations


  • Author : Michael Cheng
  • Publisher : World Health Organization
  • Release Date : 2003-09-16
  • Genre: Medical
  • Pages : 54
  • ISBN 10 : 9789241546188

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Medical Device Regulations Excerpt :

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.

Handbook of Medical Device Regulatory Affairs in Asia Book

Handbook of Medical Device Regulatory Affairs in Asia


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Genre: Medical
  • Pages : 494
  • ISBN 10 : 9780429996764

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Handbook of Medical Device Regulatory Affairs in Asia Excerpt :

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.

Medical Devices and the Public s Health Book

Medical Devices and the Public s Health


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2011-10-25
  • Genre: Medical
  • Pages : 318
  • ISBN 10 : 9780309212458

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Medical Devices and the Public s Health Excerpt :

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Medical Equipment Maintenance Book

Medical Equipment Maintenance


  • Author : Binseng Wang
  • Publisher : Morgan & Claypool Publishers
  • Release Date : 2012-10-01
  • Genre: Technology & Engineering
  • Pages : 87
  • ISBN 10 : 9781627050579

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Medical Equipment Maintenance Excerpt :

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 all of the relevant factors. This book presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance against equivalent performance levels at similar organizations. The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge. Table of Contents: Introduction / Regulatory Framework / Core Functions of Medical Equipment Maintenance and Management / CE Department Management / Performance Management / Discussion and Conclusions

Medical Devices Book

Medical Devices


  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2010
  • Genre: Medical
  • Pages : 147
  • ISBN 10 : 9789241564045

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Medical Devices Excerpt :

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