Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Mastering Safety Risk Management for Medical and In Vitro Devices written by Jayet Moon and published by ASQ Quality Press. This book was released on 2024-05-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

Download or read book Health and Safety Risk Management written by Tony Boyle and published by Routledge. This book was released on 2019-01-10 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 continues with a description of ISO 45001. Part 1.2 covers basic human factors including how the sense organs work and the psychology of the individual. Part 2.1 deals with more advanced techniques of risk management including advanced incident investigation, audit and risk assessment, and Part 2.2 covers a range of advanced human factors topics including human error and decision making. This authoritative treatment of health and safety risk management is essential reading for both students working towards degrees, diplomas and postgraduate or vocational qualifications, and experienced health and safety professionals, who will find it invaluable as a reference.

Download or read book Medical Devices Application of Risk Management to Medical Devices written by British Standards Institute Staff and published by . This book was released on 2009-07-31 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis (medical)

Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Safety of Electromedical Devices written by Norbert Leitgeb and published by Springer Science & Business Media. This book was released on 2010-05-06 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Principles of Risk Management and Patient Safety written by Barbara J. Youngberg and published by Jones & Bartlett Publishers. This book was released on 2010-10-15 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Risk Management and Patient Safety identifies changes in the industry and describes how these changes have influenced the functions of risk management in all aspects of healthcare. The book is divided into four sections. The first section describes the current state of the healthcare industry and looks at the importance of risk management and the emergence of patient safety. It also explores the importance of working with other sectors of the health care industry such as the pharmaceutical and device manufacturers. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition.

Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Download or read book DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Download or read book RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and published by Notion Press. This book was released on 2023-07-25 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.

Download or read book Pharmaceutical Applications written by Ponnadurai Ramasami and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-10-25 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Risk Management of Medical Devices for Healthcare Organisations written by James Mccaley and published by Academic Press. This book was released on 2016-06-01 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers designing and structuring a surveillance system to monitor medical devices Reviews current and future techniques to oversee, track, and assess medical devices within a healthcare organization Covers designing and structuring a surveillance system to monitor medical devices in order to help you comply with reforms on post market device surveillance Discusses all aspects of risk management in medical device development from ideation to application Risk Management of Medical Devices for Healthcare Organizations will help you identify what risks exist with medical devices in the context of a healthcare organization. The contents include coverage of how firms currently manage such risks (active vs. passive device surveillance), the strengths and limitations of those methods and what new directions the industry is heading to in order to optimize risk management. James McCauley has developed this book with a global audience in mind, and has prepared a comprehensive table of contents covering all aspects of risk management. This book is ideal for anyone at management level who needs to implement a risk management system for medical devices within a healthcare organization. McCauley includes information about automated reporting and analysis systems such as FAERS and DELTA systems, plus coverage of the medical device identification system US UDI. If you are researching and developing methods to survey and assess medical device safety and performance, this book will help you to generate a sound foundation in current methods for risk management of medical devices to pioneer new research. For clinical engineers, this book will help you to prevent and resolve equipment failure and any potential complications. About the author James McCauley Manager, Clinical Technology Services, Central Coast Local Health District Biomedical Engineer at Open Heart International Managing Director, M Engineering Australia Pty Ltd, trading as James McCauley & Associates

James McCauley has over 30 years of experience working in healthcare and biomedical engineering, specifically with a clinical engineering focus. At Open Heart International he supports open heart surgical teams on outreach missions and other medical specialties in developing countries. As a manager at Clinical Technology Services he is responsible for the implementation of Point of Care IVD’s, including evaluation and clinical assessment. He is also the current chairman for Biomedical Engineering Management Group NSW. James consultants for various commercial clients including Seventh Day Adventist Hospital, Medtek Pty Ltd, and the Commonwealth of Australia, represented by the Therapeutic Goods Administration. Until 2012 he was the Head of Biomedical Engineering at Royal Alexandra Hospital for Children, where he was responsible for research into and development of medical devices. He is currently the chair of the Biomedical Engineering Management Group NSW (BMEG) which represents the NSW Government, the NSW Public Health System and all 135 public hospitals in NSW.

Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

Download or read book Textbook of Patient Safety and Clinical Risk Management written by Liam Donaldson and published by Springer Nature. This book was released on 2020-12-14 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 years of professional practice, in order to have the maximum impact on clinicians' and nurses' behavior. Medical errors tend to vary with the level of proficiency and experience, and this must be taken into account in adverse events prevention. Human factors assume a decisive importance in resilient organizations, and an understanding of risk control and containment is fundamental for all medical and surgical specialties. This open access book offers recommendations and examples of how to improve patient safety by changing practices, introducing organizational and technological innovations, and creating effective, patient-centered, timely, efficient, and equitable care systems, in order to spread the quality and patient safety culture among the new generation of healthcare professionals, and is intended for residents and young professionals in different clinical specialties.

Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.