June 17, 2021

Download Ebook Free Safety Risk Management For Medical Devices

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
Author : Bijan Elahi
Publisher : Academic Press
Release Date : 2018-06-29
Category : Technology & Engineering
Total pages :424
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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

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 Date : 2020-08-31
Category : Computers
Total pages :270
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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 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, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Medical Devices. Application of Risk Management to Medical Devices

Medical Devices. Application of Risk Management to Medical Devices
Author : British Standards Institute Staff,British Standards Institution,International Organization for Standardization
Publisher : Unknown
Release Date : 2009-07-31
Category : Health risk assessment
Total pages :96
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Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis (medical)

Safety of Electromedical Devices

Safety of Electromedical Devices
Author : Norbert Leitgeb
Publisher : Springer Science & Business Media
Release Date : 2010-05-06
Category : Technology & Engineering
Total pages :233
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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 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 surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

Develop Precautionary Measures

Develop Precautionary Measures
Author : Shirly Tally
Publisher : Unknown
Release Date : 2021-03-17
Category :
Total pages :72
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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 explanations that can be used to develop precautionary measures that can reduce identified risks. Reducing risks can prevent injuries, illnesses, and property damage caused by workplace accidents. Preventing these accidents can save money while improving the safety of employees while at work. Buy this book now.

Plant, Technology and Safety Management (Monograph 2, 1988)

Plant, Technology and Safety Management (Monograph 2, 1988)
Author : Anonim
Publisher : Unknown
Release Date : 1988-06-01
Category : Medical instruments and apparatus
Total pages :36
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The Medical Device Industry

The Medical Device Industry
Author : John Burton
Publisher : Cambridge Scholars Publishing
Release Date : 2009-03-26
Category : Law
Total pages :200
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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 slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.

2008 Healthcare Standards Official Directory

2008 Healthcare Standards Official Directory
Author : ECRI Institute Staff,Ecri
Publisher : Ecri
Release Date : 2007-12
Category :
Total pages :2500
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American Book Publishing Record

American Book Publishing Record
Author : Anonim
Publisher : Unknown
Release Date : 2006
Category : American literature
Total pages :129
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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 Date : 2019-04-04
Category : Medical
Total pages :284
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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 a purely based on the several national and international healthcare accreditation standards in healthcare service.

Biomedical Engineering and Design Handbook, Volume 2

Biomedical Engineering and Design Handbook, Volume 2
Author : Myer Kutz
Publisher : McGraw Hill Professional
Release Date : 2009-07-13
Category : Technology & Engineering
Total pages :816
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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 design, and clinical engineering. Filled with more than 400 detailed illustrations, this definitive volume examines cutting-edge design and development methods for innovative devices, techniques, and treatments. Volume 2 covers: Medical Product Design FDA Medical Device Requirements Cardiovascular Devices Design of Respiratory Devices Design of Artificial Kidneys Design of Controlled-Release Drug Delivery Systems Sterile Medical Device Package Development Design of Magnetic Resonance Systems Instrumentation Design for Ultrasonic Imaging The Principles of X-Ray Computed Tomography Nuclear Medicine Imaging Instrumentation Breast Imaging Systems Surgical Simulation Technologies Computer-Integrated Surgery and Medical Robotics Technology and Disabilities Applied Universal Design Design of Artificial Arms and Hands for Prosthetic Applications Design of Artificial Limbs for Lower Extremity Amputees Wear of Total Knee and Hip Joint Replacements Home Modification Design Intelligent Assistive Technology Rehabilitators Risk Management in Healthcare Technology Planning for Healthcare Institutions Healthcare Facilities Planning Healthcare Systems Engineering Enclosed Habitat Life Support

Biomedical Engineering & Design Handbook, Volumes I and II

Biomedical Engineering & Design Handbook, Volumes I and II
Author : Myer Kutz
Publisher : McGraw Hill Professional
Release Date : 2009-07-13
Category : Technology & Engineering
Total pages :816
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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, and bioelectronics. Filled with more than 500 detailed illustrations, this superb volume provides the foundational knowledge required to understand the design and development of innovative devices, techniques, and treatments. Volume 2 provides timely information on breakthrough developments in medical device design, diagnostic equipment design, surgery, rehabilitation engineering, prosthetics design, and clinical engineering. Filled with more than 400 detailed illustrations, this definitive volume examines cutting-edge design and development methods for innovative devices, techniques, and treatments. Volume 1 covers: Modeling and Simulation of Biomedical Systems Bioheat Transfer Physical and Flow Properties of Blood Respiratory Mechanics and Gas Exchange Biomechanics of the Respiratory Muscles Biomechanics of Human Movement Biomechanics of the Musculoskeletal System Biodynamics Bone Mechanics Finite Element Analysis Vibration, Mechanical Shock, and Impact Electromyography Biopolymers Biomedical Composites Bioceramics Cardiovascular Biomaterials Dental Materials Orthopaedic Biomaterials Biomaterials to Promote Tissue Regeneration Bioelectricity Biomedical Signal Analysis Biomedical Signal Processing Intelligent Systems and Bioengineering BioMEMS Volume 2 covers: Medical Product Design FDA Medical Device Requirements Cardiovascular Devices Design of Respiratory Devices Design of Artificial Kidneys Design of Controlled-Release Drug Delivery Systems Sterile Medical Device Package Development Design of Magnetic Resonance Systems Instrumentation Design for Ultrasonic Imaging The Principles of X-Ray Computed Tomography Nuclear Medicine Imaging Instrumentation Breast Imaging Systems Surgical Simulation Technologies Computer-Integrated Surgery and Medical Robotics Technology and Disabilities Applied Universal Design Design of Artificial Arms and Hands for Prosthetic Applications Design of Artificial Limbs for Lower Extremity Amputees Wear of Total Knee and Hip Joint Replacements Home Modification Design Intelligent Assistive Technology Rehabilitators Risk Management in Healthcare Technology Planning for Healthcare Institutions Healthcare Facilities Planning Healthcare Systems Engineering Enclosed Habitat Life Support

Biological Safety & European Medical Device Regulations

Biological Safety & European Medical Device Regulations
Author : Anonim
Publisher : Quality First International
Release Date : 2021
Category :
Total pages :129
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Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices
Author : Anonim
Publisher : Unknown
Release Date : 2009
Category : Biomedical engineering
Total pages :21
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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 biological safety of the medical device.

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 Date : 2020-09-24
Category :
Total pages :124
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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 or patient in need of medical devices or therapeutic devices. The benefits of well executed design controls support a device and product development lifecycle that ensures the intended use is met and verified during the product development process and beyond. Best practice and compliant application of design controls depends on input definition, appropriate review of inputs and a continuous verification and validation to provide outputs. Design Control regulations ensure that good quality management (QM) practices are used for the design of medical devices and products remain fit for purpose and appropriate to the intended use. Adding to the design control requirements for manufacturers is the science of risk management applied to devices and products across the lifecycle of each product.Risk needs to be a continuous consideration and is not just a static or once off activity. The approach to risk must be suitable for the device in question. A Risk plan should lay out the approach, requirements and techniques used to assess risk and complete risk analysis. Any risks that remain must have a clinical benefit and must be managed ensuring residual risks are as low as possible. Therefore, an integrated approach to design, risk management and manufacturing creates a template for safe and effective products. Recent regulatory requirements that will shape the future of medical device regulation have gained increasing importance. Such regulation is the Medical device regulation prescribed by the European Union, MDR 2017/745 and associated amendments. These requirements shape the manner of an organizations management of risk and the safety of users. Any risk assessments depend on the design features of a device, and how well they are implemented, verified and validated. Only a well-planned and well-maintained quality management system, cognizant of regulation, design management and risk management will achieve compliance and success.