Download or read book Iso 13485 En 46000 Requirements written by Lynette Lyle Howard and published by . This book was released on 1998-07-01 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Download or read book Intelligent Autonomous Systems 12 written by Sukhan Lee and published by Springer Science & Business Media. This book was released on 2012-10-17 with total page 875 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intelligent autonomous systems are emerged as a key enabler for the creation of a new paradigm of services to humankind, as seen by the recent advancement of autonomous cars licensed for driving in our streets, of unmanned aerial and underwater vehicles carrying out hazardous tasks on-site, and of space robots engaged in scientific as well as operational missions, to list only a few. This book aims at serving the researchers and practitioners in related fields with a timely dissemination of the recent progress on intelligent autonomous systems, based on a collection of papers presented at the 12th International Conference on Intelligent Autonomous Systems, held in Jeju, Korea, June 26-29, 2012. With the theme of “Intelligence and Autonomy for the Service to Humankind, the conference has covered such diverse areas as autonomous ground, aerial, and underwater vehicles, intelligent transportation systems, personal/domestic service robots, professional service robots for surgery/rehabilitation, rescue/security and space applications, and intelligent autonomous systems for manufacturing and healthcare. This volume 2 includes contributions devoted to Service Robotics and Human-Robot Interaction and Autonomous Multi-Agent Systems and Life Engineering.

Download or read book Guidelines for Failure Modes and Effects Analysis for Medical Devices written by Dyadem Press and published by CRC Press. This book was released on 2018-06-28 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Download or read book Frontiers of Intelligent Autonomous Systems written by Sukhan Lee and published by Springer. This book was released on 2012-12-15 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This carefully edited volume aims at providing readers with the most recent progress on intelligent autonomous systems, with its particular emphasis on intelligent autonomous ground, aerial and underwater vehicles as well as service robots for home and healthcare under the context of the aforementioned convergence. “Frontiers of Intelligent Autonomous Systems” includes thoroughly revised and extended papers selected from the 12th International Conference on Intelligent Autonomous Systems (IAS-12), held in Jeju, Korea, June 26-29, 2012. The editors chose 35 papers out of the 202 papers presented at IAS-12 which are organized into three chapters: Chapter 1 is dedicated to autonomous navigation and mobile manipulation, Chapter 2 to unmanned aerial and underwater vehicles and Chapter 3 to service robots for home and healthcare. To help the readers to easily access this volume, each chapter starts with a chapter summary introduced by one of the editors: Chapter 1 by Sukhan Lee, Chapter 2 by Kwang Joon Yoon and Chapter 3 by Jangmyung Lee.

Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-10 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Download or read book The Quality Improvement Glossary written by Donald L. Siebels and published by Quality Press. This book was released on 2004-05-01 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: The benefits of using quality improvement techniques are well documented, and there are numerous books on the market explaining how to use these techniques in nearly every industry. But the world of quality is rife with unique and specific terminology, acronyms, catchphrases, theories, and noteworthy individuals. The breadth of material can be very confusing to anyone, and outright intimidating to those just beginning in the quality profession. Finally there is help!!--nl--Novices as well as seasoned quality professionals will find The Quality Improvement Glossary to be the definitive source for quality-related terms, concepts, persons, and acronyms, making it an invaluable addition to any quality library. Written to serve as an easy-to-use guide to the often confusing world of quality improvement, it provides solid and concise explanations of more than 2,500 terms, as well as references to related concepts and information on how to uncover more in-depth information. Also included in its several appendices are noted influential persons in the quality field, a separate list of acronyms, SPC symbols and common formulas. With a plethora of quality-related knowledge at readers’ fingertips, this book is also very helpful when preparing for certification exams PRAISE FOR The Quality Improvement Glossary "I currently hold three ASQ Certifications and I have to say that the easy access and reference to terms helped in my success in passing these exams." Earl Wells First Vice President, Quality & Research Allen Canning Company

Download or read book HIMSS Dictionary of Health Information and Technology Terms Acronyms and Organizations written by Healthcare Information & Management Systems Society (HIMSS) and published by CRC Press. This book was released on 2024-07-29 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: This significantly expanded and newest edition of the bestselling HIMSS Dictionary of Health Information Technology Terms, Acronyms, and Organizations has been developed and extensively reviewed by more than 50 industry experts. The sixth edition of this dictionary serves as a quick reference for students, health information technology professionals, and healthcare executives to better navigate the ever-growing health IT field and includes new terms used as a result of the COVID-19 pandemic and will serve as a resource for HIMSS’ new certification based on digital health transformation as well as for those taking the CPHIMS and CAHIMS certification exams. This valuable resource includes more than 3,000 definitions, 30 organizations, and numerous new references. Definitions of terms for the information technology and clinical, medical, and nursing informatics fields are updated and included. This sixth edition also includes an acronym list with cross-references to current definitions, new word-search capability, and a list of health IT-related associations and organizations, including contact information, mission statements, and web addresses. Academic and certification credentials are also included.

Download or read book Bioceramics in Joint Arthroplasty written by Hartmut Zippel and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dear Colleague and Participant of Bioceramics in Joint Arthroplasty 8'h Biolox" Symposium It is a pleasure for us to be able to present you with the proceedings of this Symposium. This is something that we are very proud of, as it is the first time that we have been able to achieve our objective of distributing this collection of all presentations made at this Symposium in a printed form at this time. The achievement of this goal was reached in great part as a result of the excellent cooperation of all of the speakers as well as the commitment of the publishing house to assist us in every way possible to meet the strict deadlines imposed. Additionally, a special thanks must also be given to some very special people who diligently worked to make sure our objective was met. They are: Gertrud Volkert. M. D. and Petra Elster of the Steinkopff Verlag Publishing company and our own Symposium Administrator, Hedi Kissinger. We believe that you will find this book to be a valuable and useful addition to your reference library. We hope that within its covers, you will find the most up to date scientific and clinical information regarding the use of ceramic solutions to address wear related problems in Orthopedic Surgery.

Download or read book Mastering and Managing the FDA Maze Second Edition written by Gordon Harnack and published by Quality Press. This book was released on 2014-04-14 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

Download or read book HIMSS Dictionary of Health Information Technology Terms Acronyms and Organizations written by Himss and published by CRC Press. This book was released on 2017-03-03 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: This significantly expanded and newest edition of the bestselling HIMSS Dictionary of Health Information Technology Terms, Acronyms, and Organizations has been developed and extensively reviewed by more than 50 industry experts. The fourth edition of this dictionary serves as a quick reference for students, health information technology professionals and healthcare executives to better navigate the ever-growing health IT field. This valuable resource includes more than 3000 definitions, 30 new organizations and 76 new references. Definitions of terms for the information technology and clinical, medical and nursing informatics fields are updated and included. This fourth edition also includes an acronyms list with cross references to current definitions, new word-search capability, and a list of health IT-related associations and organizations, including contact information, mission statements and web addresses. Academic and certification credentials are also included. HIMSS North America, a business unit within HIMSS, positively transforms health and healthcare through the best use of information technology in the United States and Canada. As a cause-based non-profit, HIMSS North America provides thought leadership, community building, professional development, public policy, and events. HIMSS North America represents 64,000 individual members, 640 corporate members, and over 450 non-profit organizations. Thousands of volunteers work with HIMSS to improve the quality, cost-effectiveness, access, and value of healthcare through IT. HIMSS Vision Better health through information technology. HIMSS Mission Globally, lead endeavors optimizing health engagements and care outcomes through information technology.

Download or read book Latex 2002 written by and published by iSmithers Rapra Publishing. This book was released on 2002-12 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: Both synthetic and natural latices were covered in this conference, including natural rubber latex, high volume synthetic emulsions, such as SBR, as well as specialty products, such as acrylics. Application markets addressed included adhesives and sealants, carpet backing, paper coatings, construction, fabrics, foamed articles, medical gloves, medical devices, textile threads, condoms and others. The latex industry is in dynamic flux at the present time. The supply side has undergone major restructuring. Inter-materials competition has intensified as improved materials become capable of challenging incumbent materials. Many serious issues face the latex industry, such as continuing price depression in some sectors, rising technical demands as well as substantial legislative and environmental pressure. Despite the challenging times facing the industry, the overall prospects for latex are very positive. Substitution of solvent based products continues, the performances of latices continues to improve in such applications as adhesives and the glove industry is responding positively to the setbacks of the allergy controversy. 9 million dry tons and has spread across a wide range of industrial and consumer markets. Growing demand in medical and strong prospects in construction are just two of the positive trends that will continue to fuel the market growth of both natural and synthetic latices. As last year's conference demonstrated, the Rapra International Latex Conference is an unparalleled forum for developing understanding of the latex industry, technical trends and market driving forces, such as new legislation. The 2002 event provided a vital meeting point for the synthetic and natural latex communities of Europe, Asia and America. This conference will be of interest to all latex stakeholders, including: feedstock suppliers, latex producers, compounders, fabricators of consumer, medical and industrial articles based on latex, traders and distributors, machine and equipment suppliers, legislators, healthcare professionals and users of latex based products.

Download or read book HIMSS Dictionary of Healthcare Information Technology Terms Acronyms and Organizations Third Edition written by HIMSS and published by HIMSS. This book was released on 2013 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This bestselling health IT dictionary has been significantly expanded in its third edition. This timely dictionary has been developed and extensively reviewed by more than 50 industry experts. It contains more than 2,900 health IT and related terms and acronyms, and includes mission summaries and contact information for more than 330 healthcare organizations and associations. The HIMSS Dictionary of Healthcare Information Technology Terms, Acronyms and Organizationsis the ideal quick reference for health IT professionals and the essential resource for executives, clinicians, academics, consultants, government staff and other professionals who need a reference tool for understanding the terminology and acronyms for this growing field. This valuable resource includes: definition of terms for the information technology and clinical, medical, and nursing informatics fields; acronyms with cross-references to current definitions; a list of health IT-related associations and organizations, including contact information, mission statements, and web addresses; academic and certification credentials used in healthcare.

Download or read book Write It Down written by Janet Gough and published by CRC Press. This book was released on 2005-03-30 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective

Download or read book Pharmaceutical and Medical Device Safety written by Sonia Macleod and published by Bloomsbury Publishing. This book was released on 2019-02-21 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.

Download or read book Consultants and Consulting Organizations Directory written by and published by . This book was released on 2006 with total page 1714 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Hazardous Waste Analysis written by Shane S. Que Hee and published by . This book was released on 1999 with total page 890 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than just a "how-to" book, Hazardous Waste Analysis provides practical information on state-of-the-art sampling, field analysis, and laboratory-analysis methods. It defines the legal requirements of hazard identification; discusses the regulatory requirements relevant to industrial hygiene, safety, and engineering personnel; and examines the scientific concepts necessary to understand future developments.