Safety Risk Management for Medical Devices

Written By Bijan Elahi
Safety Risk Management for Medical Devices
  • Publsiher : Academic Press
  • Release : 11 November 2021
  • ISBN : 0323918239
  • Pages : 534 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 11 November 2021, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release Date : 2021-11-11
  • Total pages : 534
  • ISBN : 0323918239
GET BOOK

Summary : Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current ...

Medical Devices Application of Risk Management to Medical Devices

Medical Devices  Application of Risk Management to Medical Devices
  • Author : British Standards Institute Staff
  • Publisher : Unknown
  • Release Date : 2001-03
  • Total pages : 50
  • ISBN : 0323918239
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Summary : Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures...

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 : 0323918239
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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 ...

Develop Precautionary Measures

Develop Precautionary Measures
  • Author : Shirly Tally
  • Publisher : Unknown
  • Release Date : 2021-03-17
  • Total pages : 72
  • ISBN : 0323918239
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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 ...

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 : 0323918239
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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 ...

Plant Technology and Safety Management Monograph 2 1988

Plant  Technology and Safety Management  Monograph 2  1988
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1988-06-01
  • Total pages : 36
  • ISBN : 0323918239
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Summary : Download or read online Plant Technology and Safety Management Monograph 2 1988 written by , published by which was released on 1988-06-01. Get Plant Technology and Safety Management Monograph 2 1988 Books now! Available in PDF, ePub and Kindle....

Design Control Medical Device Risk and Medical Device Regulation MDR 2017 745

Design Control  Medical Device Risk and Medical Device Regulation  MDR 2017 745
  • Author : Des O'Brien
  • Publisher : Unknown
  • Release Date : 2020-09-24
  • Total pages : 124
  • ISBN : 0323918239
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Summary : This short book is a starting point to introduce Design control, risk management and regulatory impact and application of Medical Device Directive MDR 2017/745 or to give its full name- Regulation (Eu) 2017/745 Of The European Parliament And Of The Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 ...

Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2009
  • Total pages : 21
  • ISBN : 0323918239
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Summary : ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the ...

Trends in Development of Medical Devices

Trends in Development of Medical Devices
  • Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
  • Publisher : Academic Press
  • Release Date : 2020-01-25
  • Total pages : 216
  • ISBN : 0323918239
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Summary : Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and ...

Cybersecurity for Connected Medical Devices

Cybersecurity for Connected Medical Devices
  • Author : Arnab Ray
  • Publisher : Academic Press
  • Release Date : 2021-11-09
  • Total pages : 332
  • ISBN : 0323918239
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Summary : The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity ...

Medical Device Innovation Handbook

Medical Device Innovation Handbook
  • Author : William Durfee,Paul Iaizzo
  • Publisher : Lulu.com
  • Release Date : 2016
  • Total pages : 95
  • ISBN : 0323918239
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Summary : Download or read online Medical Device Innovation Handbook written by William Durfee,Paul Iaizzo, published by Lulu.com which was released on 2016. Get Medical Device Innovation Handbook Books now! Available in PDF, ePub and Kindle....

Advances in Systems Safety

Advances in Systems Safety
  • Author : Chris Dale,Tom Anderson
  • Publisher : Springer Science & Business Media
  • Release Date : 2010-11-29
  • Total pages : 315
  • ISBN : 0323918239
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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 ...

Quality Risk Management in the FDA Regulated Industry

Quality Risk Management in the FDA Regulated Industry
  • Author : José Rodríguez Pérez
  • Publisher : Quality Press
  • Release Date : 2012-06-12
  • Total pages : 288
  • ISBN : 0323918239
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Summary : Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and ...

Guidelines for Failure Modes and Effects Analysis for Medical Devices

Guidelines for Failure Modes and Effects Analysis for Medical Devices
  • Author : Dyadem Press
  • Publisher : CRC Press
  • Release Date : 2018-06-28
  • Total pages : 190
  • ISBN : 0323918239
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Summary : Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure ...

Digital Human Modeling and Applications in Health Safety Ergonomics and Risk Management Human Body and Motion

Digital Human Modeling and Applications in Health  Safety  Ergonomics and Risk Management  Human Body and Motion
  • Author : Vincent G. Duffy
  • Publisher : Springer
  • Release Date : 2019-07-10
  • Total pages : 528
  • ISBN : 0323918239
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Summary : This two-volume set LNCS 11581 and 11582 constitutes the thoroughly refereed proceedings of the 10th International Conference on Digital Human Modeling and Applications in Health, Safety, Ergonomics and Risk Management, DHM 2019, which was held as part of the 21st HCI International Conference, HCII 2019, in Orlando, FL, USA, in July 2019. The total of 1275 ...