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 : /5 from reviews
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Download or read book entitled Safety Risk Management for Medical Devices by author: Bijan Elahi which was release on 29 June 2018 and published by Academic Press with total page 424 pages . This book available in PDF, EPUB and Kindle Format. 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 : 2021-04-11
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Read online Exam Prep Flash Cards for Safety Risk Management for Medical written by , published by which was released on . Download full Exam Prep Flash Cards for Safety Risk Management for Medical Books now! Available in PDF, ePub and Kindle....

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2020-09-02
  • Total pages : 976
  • ISBN : 0128130997
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Summary : The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase ...

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Develop Precautionary Measures
  • Author : Shirly Tally
  • Publisher : Unknown
  • Release Date : 2021-03-17
  • Total pages : 72
  • ISBN : 0128130997
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Summary : Risk management is the identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities. The purpose of risk management is not to eliminate all risks. It is ...

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
  • Author : Shayne C. Gad
  • Publisher : Springer Nature
  • Release Date : 2020-02-24
  • Total pages : 490
  • ISBN : 0128130997
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Summary : While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and ...

Biological Safety European Medical Device Regulations

Biological Safety   European Medical Device Regulations
  • Author : Anonim
  • Publisher : Quality First International
  • Release Date : 2021-04-11
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Read online Biological Safety European Medical Device Regulations written by , published by Quality First International which was released on . Download full Biological Safety European Medical Device Regulations Books now! Available in PDF, ePub and Kindle....

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Advances in Systems Safety
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  • Publisher : Springer Science & Business Media
  • Release Date : 2010-11-29
  • Total pages : 315
  • ISBN : 0128130997
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Summary : Advances in Systems Safety contains the papers presented at the nineteenth annual Safety-Critical Systems Symposium, held at Southampton, UK, in February 2011. The Symposium is for engineers, managers and academics in the field of system safety, across all industry sectors, so the papers making up this volume offer a wide-ranging coverage ...

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 : 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. Download full Medical Equipment Management Manual Books now! Available in PDF, ePub and Kindle....

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  • 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....

The Directory of Executive Recruiters 2003

The Directory of Executive Recruiters 2003
  • Author : Kennedy Information
  • Publisher : Unknown
  • Release Date : 2002
  • Total pages : 1128
  • ISBN : 0128130997
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Summary : Whether an executive is seeking a position at a microbrewery or SAP software consulting firm, The Directory of Executive Recruiters has the contacts who can make or break a job search. Known to insiders since 1971 as the Red Book, the 2003 edition contains detailed information on over 14,700 recruiters at more than 7,800 ...

Preventing Medical Device Recalls

Preventing Medical Device Recalls
  • Author : Dev Raheja
  • Publisher : CRC Press
  • Release Date : 2014-07-25
  • Total pages : 230
  • ISBN : 0128130997
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Summary : A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks. Based on the author’...

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 : Read online 2008 Healthcare Standards Official Directory written by ECRI Institute Staff,Ecri, published by Ecri which was released on 2007-12. Download full 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
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  • ISBN : 0128130997
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Summary : Read online American Book Publishing Record written by , published by which was released on 2006. Download full American Book Publishing Record Books now! Available in PDF, ePub and Kindle....

Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2007

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  • Author : United States. Congress. House. Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 0128130997
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Summary : Read online Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2007 written by United States. Congress. House. Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, published by which was released on 2006. Download full Agriculture Rural Development Food and Drug Administration ...

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 ...