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 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

Produk Detail:

  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Pages : 424 pages
  • ISBN : 0128130997
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKSafety Risk Management for Medical Devices

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

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 01 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

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,

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

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 : 25 January 2020
GET THIS BOOKTrends in Development of Medical Devices

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 benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this

Medical Device Software Verification, Validation and Compliance

Medical Device Software Verification, Validation and Compliance
  • Author : David A. Vogel
  • Publisher : Artech House
  • Release : 17 January 2021
GET THIS BOOKMedical Device Software Verification, Validation and Compliance

HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows:

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release : 18 August 2015
GET THIS BOOKMedical Devices

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to

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,

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,

Handbook of Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition

Handbook of Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition
  • Author : Pascale Carayon
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKHandbook of Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition

The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human factors and ergonomics issues such as human error or design of medical devices or a specific application such as emergency medicine. This book draws on both

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

Systems, Software and Services Process Improvement

Systems, Software and Services Process Improvement
  • Author : Rory V. O’Connor,Mariye Umay Akkaya,Kerem Kemaneci,Murat Yilmaz,Alexander Poth,Richard Messnarz
  • Publisher : Springer
  • Release : 15 October 2015
GET THIS BOOKSystems, Software and Services Process Improvement

This volume constitutes the refereed proceedings of the 22st EuroSPI conference, held in Ankara, Turkey, in September/October 2015.The 18 revised papers presented together with 9 selected key notes and workshop papers were carefully reviewed and selected from 49 submissions. They are organized in topical sections on SPI themed case studies; SPI approaches in safety-critical domains; SPI in social and organizational issues; software process improvement best practices; models and optimization approaches in SPI; SPI and process assessment; creating environments supporting innovation and improvement;

Reliable Design of Medical Devices

Reliable Design of Medical Devices
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release : 21 November 2005
GET THIS BOOKReliable Design of Medical Devices

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects