Managing 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, 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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  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Pages : 380 pages
  • ISBN : 0128041927
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKManaging Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release : 10 September 2016
GET THIS 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,

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 Publisher
  • Release : 09 May 2017
GET THIS 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.

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.

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 Devices and the Public's Health

Medical Devices and the Public's Health
  • 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 : 25 October 2011
GET THIS BOOKMedical Devices and the Public's Health

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 Regulatory Affairs

Medical Regulatory Affairs
  • Author : Jack Wong,Raymond K. Y. Tong
  • Publisher : CRC Press
  • Release : 27 January 2022
GET THIS BOOKMedical Regulatory Affairs

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

Innovation and Protection

Innovation and Protection
  • Author : I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar
  • Publisher : Cambridge University Press
  • Release : 31 March 2022
GET THIS BOOKInnovation and Protection

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

Healing the Pharmacy of the World

Healing the Pharmacy of the World
  • Author : K.L. Sharma
  • Publisher : Notion Press
  • Release : 30 August 2021
GET THIS BOOKHealing the Pharmacy of the World

Indian pharmaceutical industry, it is argued, has democratized the availability, accessibility and affordability of medicines. Everyone, rich or poor, can now get them at a fraction of the cost of branded drugs. However, the allegations about their suspect quality, if true, pose questions of life-and-death for the unsuspecting consumers. Is it the messiah supplying the low-cost quality medicines across the globe or is it the precursor for the ultimate indigence of the unsuspecting millions consuming poor-quality generic medicines? In the

Safe Medical Devices for Children

Safe Medical Devices for Children
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
  • Publisher : National Academies Press
  • Release : 20 January 2006
GET THIS BOOKSafe Medical Devices for Children

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical

Blockchain Technology and Innovations in Business Processes

Blockchain Technology and Innovations in Business Processes
  • Author : Srikanta Patnaik,Tao-Sheng Wang,Tao Shen,Sushanta Kumar Panigrahi
  • Publisher : Springer Nature
  • Release : 24 March 2021
GET THIS BOOKBlockchain Technology and Innovations in Business Processes

This edited book provides a platform to bring together researchers, academia and industry collaborators to exchange their knowledge and work to develop better understanding about the scope of blockchain technology in business management applications of different sectors such as retail sector, supply chain and logistics, healthcare sector, manufacturing sector, judiciary, finance and government sector in terms of data quality and timeliness. The book presents original unpublished research papers on blockchain technology and business management on novel architectures, prototypes and case

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

Medical Device Regulations

Medical Device Regulations
  • Author : Aakash Deep
  • Publisher : Academic Press
  • Release : 13 January 2022
GET THIS 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

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

Medical Device Design

Medical Device Design
  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release : 17 December 2012
GET THIS BOOKMedical Device Design

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
  • Author : Institute of Medicine,Committee on Technological Innovation in Medicine
  • Publisher : National Academies Press
  • Release : 01 February 1991
GET THIS BOOKThe Changing Economics of Medical Technology

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policies--as well as the involvement of numerous government agencies--affect