preventing medical device recalls

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Preventing Medical Device Recalls

Author : Dev Raheja
ISBN : 9781466568235
Genre : Business & Economics
File Size : 56. 62 MB
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A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks. Based on the author’s extensive experience in the medical device, aerospace, and manufacturing engineering industries, Preventing Medical Device Recalls presents a detailed structure for systems thinking that can help to prevent costly device recalls. Based on Dr. W. Edwards Deming’s System of Profound Knowledge, this structure can help medical device designers and manufacturers exceed their customers’ expectations for quality and safety. This book is among the first to demonstrate how to control safety risks—from specifications all the way through to safely retiring products without harm to the environment. Supplying an accessible overview of medical device requirements and the science of safety, it explains why risk analysis must start with product specification and continue throughout the product life cycle. Covering paradigms for proactive thinking and doing, the text details methods that readers can implement during the specification writing, product design, and product development phases to prevent recalls. It also includes numerous examples from the author’s experience in the medical device, consumer, and aerospace industries. Even in healthcare, where compliance with standards is at its highest level, more patients die from medical mistakes each week than would be involved in a jumbo jet crash. With coverage that includes risk assessment and risk management, this book provides you with an understanding of how mishaps happen so you can account for unexpected events and design devices that are free of costly recalls.

Design For Safety

Author : Louis J. Gullo
ISBN : 9781118974315
Genre : Technology & Engineering
File Size : 61. 56 MB
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A one-stop reference guide to design for safety principles and applications Design for Safety (DfSa) provides design engineers and engineering managers with a range of tools and techniques for incorporating safety into the design process for complex systems. It explains how to design for maximum safe conditions and minimum risk of accidents. The book covers safety design practices, which will result in improved safety, fewer accidents, and substantial savings in life cycle costs for producers and users. Readers who apply DfSa principles can expect to have a dramatic improvement in the ability to compete in global markets. They will also find a wealth of design practices not covered in typical engineering books—allowing them to think outside the box when developing safety requirements. Design Safety is already a high demand field due to its importance to system design and will be even more vital for engineers in multiple design disciplines as more systems become increasingly complex and liabilities increase. Therefore, risk mitigation methods to design systems with safety features are becoming more important. Designing systems for safety has been a high priority for many safety-critical systems—especially in the aerospace and military industries. However, with the expansion of technological innovations into other market places, industries that had not previously considered safety design requirements are now using the technology in applications. Design for Safety: Covers trending topics and the latest technologies Provides ten paradigms for managing and designing systems for safety and uses them as guiding themes throughout the book Logically defines the parameters and concepts, sets the safety program and requirements, covers basic methodologies, investigates lessons from history, and addresses specialty topics within the topic of Design for Safety (DfSa) Supplements other books in the series on Quality and Reliability Engineering Design for Safety is an ideal book for new and experienced engineers and managers who are involved with design, testing, and maintenance of safety critical applications. It is also helpful for advanced undergraduate and postgraduate students in engineering. Design for Safety is the second in a series of “Design for” books. Design for Reliability was the first in the series with more planned for the future.

Medical Device Recalls

Author : United States. General Accounting Office
ISBN : UOM:39015042649759
Genre : Medical instruments and apparatus
File Size : 45. 79 MB
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Development Of Fda Regulated Medical Products Second Edition

Author : Elaine Whitmore
ISBN : 9780873898331
Genre : Business & Economics
File Size : 67. 98 MB
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Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates.

Medical Technology

Author : United States. General Accounting Office
ISBN : UOM:39015022612801
Genre : Medical instruments and apparatus
File Size : 76. 83 MB
Format : PDF
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Safe And Sound Software

Author : Thomas H. Faris
ISBN : 0873896742
Genre : Business & Economics
File Size : 41. 1 MB
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"This book provides information and recommendations to help regulatory affairs and quality managers, and consultants of software medical device design and development organizations, navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system. Software organization executives, functional managers, and other interested coworkers can also use this book to secure a general understanding of the subject matter."--BOOK JACKET.

Loyola Consumer Law Review

Author :
ISBN : STANFORD:36105062021915
Genre : Consumer protection
File Size : 87. 20 MB
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Federal Register

Author :
ISBN : UCR:31210024751586
Genre : Delegated legislation
File Size : 32. 20 MB
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The Biomedical Quality Auditor Handbook Second Edition

Author : ASQ Biomedical Division
ISBN : 9780873898362
Genre : Business & Economics
File Size : 84. 91 MB
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This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.

Reliability Technology Human Error And Quality In Health Care

Author : B.S. Dhillon
ISBN : 1420065599
Genre : Technology & Engineering
File Size : 48. 49 MB
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The effective and interrelated functioning of system reliability technology, human factors, and quality play an important role in the appropriate, efficient, and cost-effective delivery of health care. Simply put, it can save you time, money, and more importantly, lives. Over the years a large number of journal and conference proceedings articles on these topics have been published, but there are only a small number of books written on each individual topic, and virtually none that brings the pieces together into a unified whole.

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