Safety Risk Management for Medical Devices

Written By Bijan Elahi
Safety Risk Management for Medical Devices
  • Publsiher : Academic Press
  • Release : 29 June 2018
  • ISBN : 0128130997
  • Pages : 424 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Safety Risk Management for Medical Devices written by Bijan Elahi which was release on 29 June 2018, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971—a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices. Teaches industry best practices on medical-device risk management in compliance with ISO 14971 Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devices Offers a worked-out example applying the risk management process on a hypothetical device

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release Date : 2018-06-29
  • Total pages : 424
  • ISBN : 0128130997
GET BOOK

Summary : Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to ...

Exam Prep Flash Cards for Safety Risk Management for Medical

Exam Prep Flash Cards for Safety Risk Management for Medical
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2021-05-09
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Download or read online Exam Prep Flash Cards for Safety Risk Management for Medical written by , published by which was released on . Get Exam Prep Flash Cards for Safety Risk Management for Medical Books now! Available in PDF, ePub and Kindle....

Medical Device Cybersecurity for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers
  • Author : Axel Wirth,Christopher Gates,Jason Smith
  • Publisher : Artech House
  • Release Date : 2020-08-31
  • Total pages : 270
  • ISBN : 0128130997
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Summary : Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a ...

Medical Equipment Management Manual

Medical Equipment Management Manual
  • Author : Robert H. Stiefel,Association for the Advancement of Medical Instrumentation
  • Publisher : Association for the Advancement of Medical Instrumentation (AAMI)
  • Release Date : 2004
  • Total pages : 122
  • ISBN : 0128130997
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Summary : Download or read online Medical Equipment Management Manual written by Robert H. Stiefel,Association for the Advancement of Medical Instrumentation, published by Association for the Advancement of Medical Instrumentation (AAMI) which was released on 2004. Get Medical Equipment Management Manual Books now! Available in PDF, ePub and Kindle....

Safety of Electromedical Devices

Safety of Electromedical Devices
  • Author : Norbert Leitgeb
  • Publisher : Springer Science & Business Media
  • Release Date : 2010-05-06
  • Total pages : 233
  • ISBN : 0128130997
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Summary : Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an ...

Health Safety Management for Medical Practices

Health   Safety Management for Medical Practices
  • Author : Linda F. Chaff
  • Publisher : Amer Medical Assn
  • Release Date : 2002
  • Total pages : 314
  • ISBN : 0128130997
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Summary : This text outlines guidelines for planning the safety programme, obtaining administrative support, conducting a needs assessment, setting priorities, and developing policies and procedures, as well as information on regulatory and voluntary compliance agencies affecting health care....

2008 Healthcare Standards Official Directory

2008 Healthcare Standards Official Directory
  • Author : ECRI Institute Staff,Ecri
  • Publisher : Ecri
  • Release Date : 2007-12
  • Total pages : 2500
  • ISBN : 0128130997
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Summary : Download or read online 2008 Healthcare Standards Official Directory written by ECRI Institute Staff,Ecri, published by Ecri which was released on 2007-12. Get 2008 Healthcare Standards Official Directory Books now! Available in PDF, ePub and Kindle....

American Book Publishing Record

American Book Publishing Record
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Download or read online American Book Publishing Record written by , published by which was released on 2006. Get American Book Publishing Record Books now! Available in PDF, ePub and Kindle....

Biomedical Engineering and Design Handbook Volume 2

Biomedical Engineering and Design Handbook  Volume 2
  • Author : Myer Kutz
  • Publisher : McGraw Hill Professional
  • Release Date : 2009-07-13
  • Total pages : 816
  • ISBN : 0128130997
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Summary : A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and Applications The two-volume Biomedical Engineering and Design Handbook, Second Edition, offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from ...

Biomedical Engineering Design Handbook Volumes I and II

Biomedical Engineering   Design Handbook  Volumes I and II
  • Author : Myer Kutz
  • Publisher : McGraw Hill Professional
  • Release Date : 2009-07-13
  • Total pages : 816
  • ISBN : 0128130997
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Summary : A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and Applications The two-volume Biomedical Engineering and Design Handbook, Second Edition offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from ...

Comprehensive Perioperative Nursing Principles

Comprehensive Perioperative Nursing  Principles
  • Author : Barbara J. Gruendemann,Billie Fernsebner
  • Publisher : Jones & Bartlett Pub
  • Release Date : 1995
  • Total pages : 546
  • ISBN : 0128130997
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Summary : Download or read online Comprehensive Perioperative Nursing Principles written by Barbara J. Gruendemann,Billie Fernsebner, published by Jones & Bartlett Pub which was released on 1995. Get Comprehensive Perioperative Nursing Principles Books now! Available in PDF, ePub and Kindle....

The Management of Medical Equipment in NHS Acute Trusts in England

The Management of Medical Equipment in NHS Acute Trusts in England
  • Author : Great Britain. National Audit Office
  • Publisher : Unknown
  • Release Date : 1999
  • Total pages : 86
  • ISBN : 0128130997
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Summary : On cover & title page:NHS Executive...

Emergency Medical Services

Emergency Medical Services
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1991
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Download or read online Emergency Medical Services written by , published by which was released on 1991. Get Emergency Medical Services Books now! Available in PDF, ePub and Kindle....

Current Law Index

Current Law Index
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1996
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Download or read online Current Law Index written by , published by which was released on 1996. Get Current Law Index Books now! Available in PDF, ePub and Kindle....

Healthcare Technology Management A Systematic Approach

Healthcare Technology Management     A Systematic Approach
  • Author : Francis Hegarty,John Amoore,Paul Blackett,Justin McCarthy,Richard Scott
  • Publisher : CRC Press
  • Release Date : 2017-01-06
  • Total pages : 543
  • ISBN : 0128130997
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Summary : Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and ...