Safety 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 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

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  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Pages : 534 pages
  • ISBN : 0323918239
  • 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 : 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

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

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

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,

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

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

User Interface Requirements for Medical Devices

User Interface Requirements for Medical Devices
  • Author : Michael Wiklund,Erin Davis,Alexandria Trombley
  • Publisher : CRC Press
  • Release : 17 November 2021
GET THIS BOOKUser Interface Requirements for Medical Devices

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 the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good

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

Bow Ties in Risk Management

Bow Ties in Risk Management
  • Author : CCPS (Center for Chemical Process Safety)
  • Publisher : John Wiley & Sons
  • Release : 09 October 2018
GET THIS BOOKBow Ties in Risk Management

AN AUTHORITATIVE GUIDE THAT EXPLAINS THE EFFECTIVENESS AND IMPLEMENTATION OF BOW TIE ANALYSIS, A QUALITATIVE RISK ASSESSMENT AND BARRIER MANAGEMENT METHODOLOGY From a collaborative effort of the Center for Chemical Process Safety (CCPS) and the Energy Institute (EI) comes an invaluable book that puts the focus on a specific qualitative risk management methodology – bow tie barrier analysis. The book contains practical advice for conducting an effective bow tie analysis and offers guidance for creating bow tie diagrams for process safety

Usability Testing of Medical Devices

Usability Testing of Medical Devices
  • Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
  • Publisher : CRC Press
  • Release : 23 December 2015
GET THIS BOOKUsability Testing of Medical Devices

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

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.

Medical Devices

Medical Devices
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 01 July 2022
GET THIS BOOKMedical Devices

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Patient Safety and Quality

Patient Safety and Quality
  • Author : Anonim
  • Publisher : Unknown Publisher
  • Release : 01 July 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