Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Release Date : 11 November 2021
  • Publisher : Academic Press
  • Genre : Technology & Engineering
  • Pages : 534
  • ISBN 13 : 9780323918237

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Book Description: 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
Genre : Technology & Engineering
Get Book

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 ...

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

Author : Bijan Elahi
Publisher : Academic Press
Genre : Technology & Engineering
Get Book

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 ...

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
Genre : Medical
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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 ...

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework

Author : Beth Ann Fiedler
Publisher : Elsevier
Genre : Technology & Engineering
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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 ...

Safety of Electromedical Devices

Safety of Electromedical Devices

Author : Norbert Leitgeb
Publisher : Springer Science & Business Media
Genre : Technology & Engineering
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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 ...

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Textbook of Patient Safety and Clinical Risk Management

Author : Liam Donaldson,Walter Ricciardi,Susan Sheridan,Riccardo Tartaglia
Publisher : Springer Nature
Genre : Medical
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Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WHO surgical checklist, to adopt the most appropriate measures for the prevention of assistance-related risks, and to identify the potential ones using tools such as ...

Health and Safety  Risk Management

Health and Safety Risk Management

Author : Tony Boyle
Publisher : Routledge
Genre : Business & Economics
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Health and Safety: Risk Management is the clearest and most comprehensive book on risk management available today. This newly revised fifth edition takes into account new developments in legislation, standards and good practice. ISO 45001, the international health and safety management system standard, is given comprehensive treatment, and the latest ISO 9004 ...

DESIGN CONTROLS  RISK MANAGEMENT   PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

Author : Vernon Geckler
Publisher : Wasatch Consulting Resources LLC
Genre : Uncategorized
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This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an ...

User Interface Requirements for Medical Devices

User Interface Requirements for Medical Devices

Author : Michael Wiklund,Erin Davis,Alexandria Trombley
Publisher : CRC Press
Genre : Technology & Engineering
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This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents ...

Healthcare Hazard Control and Safety Management

Healthcare Hazard Control and Safety Management

Author : James T. Tweedy
Publisher : CRC Press
Genre : Business & Economics
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Surpassing the standard set by the first edition, Healthcare Hazard Control and Safety Management, Second Edition presents expansive coverage for healthcare professionals serving in safety, occupational health, hazard materials management, quality improvement, and risk management positions. Comprehensive in scope, the book covers all major issues i...

Usability Testing of Medical Devices

Usability Testing of Medical Devices

Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher : CRC Press
Genre : Medical
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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h...

Medical Device Cybersecurity for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers

Author : Axel Wirth,Christopher Gates,Jason Smith
Publisher : Artech House
Genre : Computers
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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 ...

Systems  Software and Services Process Improvement

Systems Software and Services Process Improvement

Author : Xabier Larrucea,Izaskun Santamaria,Rory V. O'Connor,Richard Messnarz
Publisher : Springer
Genre : Business & Economics
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This volume constitutes the refereed proceedings of the 25th European Conference on Systems, Software and Services Process Improvement, EuroSPI conference, held in Bilbao, Spain, in September 2018. The 56 revised full papers presented were carefully reviewed and selected from 95 submissions. They are organized in topical sections on SPI context and agility, SPI ...

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Publisher : National Academies Press
Genre : Medical
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The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues ...