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
GET BOOK

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 Device Regulations

Medical Device Regulations
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  • Publisher : Academic Press
  • Release Date : 2022-01-13
  • Total pages : 186
  • ISBN : 0128041927
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Summary : 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 ...

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  • Publisher : Springer Nature
  • Release Date : 2021-03-24
  • Total pages : 237
  • ISBN : 0128041927
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Summary : 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, ...

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  • Publisher : Cambridge University Press
  • Release Date : 2018-12-06
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Effective leadership is critical to ensuring safety, efficiency and maximum productivity in the operating room (OR). This practical, evidence-based book unpicks the dynamics of a successful OR environment to underline the key techniques for management of policies, systems, staff members and teams. Fully updated to include recent clinical guidelines, the ...

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  • ISBN : 0128041927
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Summary : This book features a collection of high-quality research papers presented at the International Conference on Tourism, Technology & Systems (ICOTTS 2021), held at the University of Cartagena, in Cartagena de Indias, Colombia, from 4 to 6 November 2021. The book is divided into two volumes, and it covers the areas of technology in tourism and ...

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  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Total pages : 620
  • ISBN : 0128041927
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Summary : 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 ...

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  • 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 ...

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  • Release Date : 2013-12-07
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  • ISBN : 0128041927
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Summary : 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 ...

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  • Publisher : Springer Nature
  • Release Date : 2022-05-31
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  • 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 ...

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  • Author : OECD
  • Publisher : OECD Publishing
  • Release Date : 2017-01-16
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  • ISBN : 0128041927
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Summary : This report discusses the need for an integrated and cyclical approach to managing health technology in order to mitigate clinical and financial risks, and ensure acceptable value for money....

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  • ISBN : 0128041927
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Summary : Worldwide, the population ageing is a reality. The concept of Active Ageing, adopted by the World Health Organization, aims to guarantee quality ageing and appears as a strategy to solve this demographic challenge. The technological solutions might have a key role in the promotion of human functioning and in the ...

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  • Publisher : Springer
  • Release Date : 2015-09-23
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Summary : This volume presents the proceedings of the 3rd International Conference on Nanotechnologies and Biomedical Engineering which was held on September 23-26, 2015 in Chisinau, Republic of Moldova. ICNBME-2015 continues the series of International Conferences in the field of nanotechnologies and biomedical engineering. It aims at bringing together scientists and engineers dealing ...

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  • Publisher : John Wiley & Sons
  • Release Date : 2013-05-20
  • Total pages : 600
  • ISBN : 0128041927
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Summary : This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). ...

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Summary : EU Healthcare Sector Organization, Management and Payment Systems Handbook - Strategic Information, Programs and Regulations...

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  • Author : Anonim
  • Publisher : World Health Organization
  • Release Date : 2020-12-09
  • Total pages : 212
  • ISBN : 0128041927
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Summary : Download or read online Guidance for post market surveillance and market surveillance of medical devices including in vitro diagnostics written by , published by World Health Organization which was released on 2020-12-09. Get Guidance for post market surveillance and market surveillance of medical devices including in vitro diagnostics Books now! ...