Safety Risk Management for Medical Devices

Produk Detail:
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Pages : 424 pages
  • ISBN : 0128130997
  • Rating : /5 from reviews
CLICK HERE TO GET THIS BOOK >>>Safety Risk Management for Medical Devices

Download or Read online Safety Risk Management for Medical Devices full in PDF, ePub and kindle. this book written by Bijan Elahi and published by Academic Press which was released on 29 June 2018 with total page 424 pages. We cannot guarantee that Safety Risk Management for Medical Devices book is available in the library, click Get Book button and read full online book in your kindle, tablet, IPAD, PC or mobile whenever and wherever You Like. 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 : 29 June 2018
GET THIS BOOK Safety Risk Management for Medical Devices

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

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 : 31 August 2020
GET THIS BOOK Medical Device Cybersecurity for Engineers and Manufacturers

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 book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance,

Safety of Electromedical Devices

Safety of Electromedical Devices
  • Author : Norbert Leitgeb
  • Publisher : Springer Science & Business Media
  • Release : 06 May 2010
GET THIS BOOK Safety of Electromedical Devices

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 increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or

Develop Precautionary Measures

Develop Precautionary Measures
  • Author : Shirly Tally
  • Publisher : Unknown
  • Release : 17 March 2021
GET THIS BOOK Develop Precautionary Measures

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 to minimize the potential negative consequence of risks. By working with risk managers, employees can make smart risk decisions to improve the chance of reward. This book provides information and

The Medical Device Industry

The Medical Device Industry
  • Author : John Burton
  • Publisher : Cambridge Scholars Publishing
  • Release : 26 March 2009
GET THIS BOOK The Medical Device Industry

The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been

A TEXTBOOK ON HEALTHCARE QUALITY IMPROVEMENT PATIENT SAFETY AND RISK MANAGEMENT GLOSSARY

A TEXTBOOK ON HEALTHCARE QUALITY IMPROVEMENT  PATIENT SAFETY AND RISK MANAGEMENT GLOSSARY
  • Author : Dr. Zuber M. Shaikh
  • Publisher : KY Publications
  • Release : 04 April 2019
GET THIS BOOK A TEXTBOOK ON HEALTHCARE QUALITY IMPROVEMENT PATIENT SAFETY AND RISK MANAGEMENT GLOSSARY

A glossary, also known as a vocabulary or clavis, is an alphabetical list of terms in a particular domain of knowledge with the definitions for those terms. In a general sense, a glossary contains explanations of concepts relevant to a certain field of study or action. In this book, all the terms used in healthcare quality improvement, patient safety and risk management used are elaborated with appropriate references and definitions for the students, researchers and professionals. This text book is

Biomedical Engineering and Design Handbook Volume 2

Biomedical Engineering and Design Handbook  Volume 2
  • Author : Myer Kutz
  • Publisher : McGraw Hill Professional
  • Release : 13 July 2009
GET THIS BOOK Biomedical Engineering and Design Handbook Volume 2

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 nearly 80 leading experts at universities, medical centers, and commercial and law firms. Volume 2 provides timely information on breakthrough developments in medical device design, diagnostic equipment design, surgery, rehabilitation engineering, prosthetics

Biomedical Engineering Design Handbook Volumes I and II

Biomedical Engineering   Design Handbook  Volumes I and II
  • Author : Myer Kutz
  • Publisher : McGraw Hill Professional
  • Release : 13 July 2009
GET THIS BOOK Biomedical Engineering Design Handbook Volumes I and II

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 nearly 80 leading experts at universities, medical centers, and commercial and law firms. Volume 1 focuses on the basics of biomedical engineering, including biomedical systems analysis, biomechanics of the human body, biomaterials,

Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices
  • Author : Anonim
  • Publisher : Unknown
  • Release : 19 June 2021
GET THIS BOOK Biological Evaluation of Medical Devices

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 available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the

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 : 24 September 2020
GET THIS BOOK Design Control Medical Device Risk and Medical Device Regulation MDR 2017 745

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 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.The importance of design controls manifests itself in the potential impact of device quality and safety for the public