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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publsiher : Academic Press
  • Release : 11 November 2021
  • ISBN : 0323918239
  • Pages : 534 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKSafety Risk Management for Medical Devices

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 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 : 11 November 2021
GET THIS BOOKSafety Risk Management for Medical Devices

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

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 29 June 2018
GET THIS BOOKSafety 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

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 11 February 2022
GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. It also removes the uncertainties associated with the understanding and application of international standards. Focusing exclusively on the 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 practice. This book comprehensively addresses safety risk management from the standpoint of a wide variety

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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 : 24 February 2020
GET THIS BOOKIntegrated Safety and Risk Assessment for Medical Devices and Combination Products

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 became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be

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Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release : 10 September 2016
GET THIS BOOKManaging Medical Devices within a Regulatory Framework

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 contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare,

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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
  • Release : 11 February 2017
GET THIS BOOKDESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

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 extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic,

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Health and Safety: Risk Management

Health and Safety: Risk Management
  • Author : Tony Boyle
  • Publisher : Routledge
  • Release : 16 January 2019
GET THIS BOOKHealth and Safety: Risk Management

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 and ISO 19011 have also been addressed. The book is divided into four main parts. Part 1.1 begins with a basic introduction to the techniques of health and safety risk management and

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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 BOOKMedical 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,

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Textbook of Patient Safety and Clinical Risk Management

Textbook of Patient Safety and Clinical Risk Management
  • Author : Liam Donaldson,Walter Ricciardi,Susan Sheridan,Riccardo Tartaglia
  • Publisher : Springer Nature
  • Release : 14 December 2020
GET THIS BOOKTextbook of Patient Safety and Clinical Risk Management

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 reporting & learning systems. The culture of safety in the care environment and of human factors influencing it should be developed from the beginning of medical studies and in the first

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Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
  • Author : Marie Teixeira,Richard Bradley
  • Publisher : CRC Press
  • Release : 20 September 2002
GET THIS BOOKDesign Controls for the Medical Device Industry

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

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Digital Conversion on the Way to Industry 4.0

Digital Conversion on the Way to Industry 4.0
  • Author : Numan M. Durakbasa,M. Güneş Gençyılmaz
  • Publisher : Springer Nature
  • Release : 26 November 2020
GET THIS BOOKDigital Conversion on the Way to Industry 4.0

This book presents the proceedings from the International Symposium for Production Research 2020. The cross-disciplinary papers presented draw on research from academics and practitioners from industrial engineering, management engineering, operational research, and production/operational management. It explores topics including: · computer-aided manufacturing; Industry 4.0 applications; simulation and modeling big data and analytics; flexible manufacturing systems; decision analysis quality management industrial robotics in production systems information technologies in production management; and optimization techniques. Presenting real-life applications, case studies, and mathematical models, this book is

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Pharmaceutical Applications

Pharmaceutical Applications
  • Author : Ponnadurai Ramasami
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release : 25 October 2021
GET THIS BOOKPharmaceutical Applications

Based on "The Virtual Conference on Chemistry and its Applications (VCCA-2020) – Research and Innovations in Chemical Sciences: Paving the Way Forward" held in August 2020 and organized by the Computational Chemistry Group of the University of Mauritius. The chapters reflect a wide range of fundamental and applied research in the chemical sciences and interdisciplinary subjects.

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Occupational Health and Safety in the Care and Use of Nonhuman Primates

Occupational Health and Safety in the Care and Use of Nonhuman Primates
  • Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates
  • Publisher : National Academies Press
  • Release : 13 July 2003
GET THIS BOOKOccupational Health and Safety in the Care and Use of Nonhuman Primates

The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a

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Medical Device Use Error

Medical Device Use Error
  • Author : Michael Wiklund,Andrea Dwyer,Erin Davis
  • Publisher : CRC Press
  • Release : 06 January 2016
GET THIS BOOKMedical Device Use Error

Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors

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Patient Safety and Quality

Patient Safety and Quality
  • Author : Anonim
  • Publisher : Anonim
  • Release : 27 May 2022
GET THIS BOOKPatient Safety and Quality

"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses

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