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The Iso 149712007 Essentials
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Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez
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.
Book Synopsis Excellence Beyond Compliance by : William I. White
Download or read book Excellence Beyond Compliance written by William I. White and published by Taylor & Francis. This book was released on 2018-05-16 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS.
Book Synopsis Handbook of Standards and Guidelines in Human Factors and Ergonomics, Second Edition by : Waldemar Karwowski
Download or read book Handbook of Standards and Guidelines in Human Factors and Ergonomics, Second Edition written by Waldemar Karwowski and published by CRC Press. This book was released on 2021-06-28 with total page 775 pages. Available in PDF, EPUB and Kindle. Book excerpt: With an updated edition including new material in additional chapters, this one-of-a-kind handbook covers not only current standardization efforts, but also anthropometry and optimal working postures, ergonomic human computer interactions, legal protection, occupational health and safety, and military human factor principles. While delineating the crucial role that standards and guidelines play in facilitating the design of advantageous working conditions to enhance individual performance, the handbook suggests ways to expand opportunities for global economic and ergonomic development. This book features: Guidance on the design of work systems including tasks, equipment, and workspaces as well as the work environment in relation to human capacities and limitations Emphasis on important human factors and ergonomic standards that can be utilized to improve product and process to ensure efficiency and safety A focus on quality control to ensure that standards are met throughout the worldwide market
Book Synopsis The ISO 14971:2007 Essentials by : Canadian Standards Association
Download or read book The ISO 14971:2007 Essentials written by Canadian Standards Association and published by . This book was released on 2007 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Engineering by : Azzam Taktak
Download or read book Clinical Engineering written by Azzam Taktak and published by Academic Press. This book was released on 2019-12-01 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Engineering: A Handbook for Clinical and Biomedical Engineers, Second Edition, helps professionals and students in clinical engineering successfully deploy medical technologies. The book provides a broad reference to the core elements of the subject, drawing from a range of experienced authors. In addition to engineering skills, clinical engineers must be able to work with both patients and a range of professional staff, including technicians, clinicians and equipment manufacturers. This book will not only help users keep up-to-date on the fast-moving scientific and medical research in the field, but also help them develop laboratory, design, workshop and management skills. The updated edition features the latest fundamentals of medical technology integration, patient safety, risk assessment and assistive technology. Provides engineers in core medical disciplines and related fields with the skills and knowledge to successfully collaborate on the development of medical devices, via approved procedures and standards Covers US and EU standards (FDA and MDD, respectively, plus related ISO requirements) Includes information that is backed up with real-life clinical examples, case studies, and separate tutorials for training and class use Completely updated to include new standards and regulations, as well as new case studies and illustrations
Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by William Andrew. This book was released on 2021-11-24 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. - Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data - Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management - Supports the development, marketing and commercialization of medical devices and materials for use in medical devices
Book Synopsis WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff by : World Health Organization
Download or read book WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff written by World Health Organization and published by World Health Organization. This book was released on 2020-05-11 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Safety Risk Management for Medical Devices by : Bijan Elahi
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
Book Synopsis Anesthesia Equipment E-Book by : Jan Ehrenwerth
Download or read book Anesthesia Equipment E-Book written by Jan Ehrenwerth and published by Elsevier Health Sciences. This book was released on 2013-03-12 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anesthesia Equipment: Principles and Applications, 2nd Edition, by Dr. Jan Ehrenwerth and Dr. James B. Eisenkraft, offers expert, highly visual, practical guidance on the full range of delivery systems and technology used in practice today. It equips you with the objective, informed answers you need to ensure optimal patient safety. Consult this title on your favorite e-reader with intuitive search tools and adjustable font sizes. Elsevier eBooks provide instant portable access to your entire library, no matter what device you're using or where you're located. Make informed decisions by expanding your understanding of the physical principles of equipment, the rationale for its use, delivery systems for inhalational anesthesia, systems monitoring, hazards and safety features, maintenance and quality assurance, special situations/equipment for non-routine adult anesthesia, and future directions for the field. Ensure patient safety with detailed advice on risk management and medicolegal implications of equipment use. Apply the most complete and up-to-date information available on machines, vaporizers, ventilators, breathing systems, vigilance, ergonomics, and simulation. Visualize the safe and effective use of equipment thanks to hundreds of full-color line drawings and photographs. Access the complete text and images online, fully searchable, at www.expertconsult.com.
Book Synopsis Technical Specifications for Oxygen Concentrators by : World Health Organization
Download or read book Technical Specifications for Oxygen Concentrators written by World Health Organization and published by World Health Organization. This book was released on 2016-10-25 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this guidance document is for the appropriate selection procurement utilization and maintenance of oxygen concentrators. This document also focuses on recommendations for the appropriate use and maintenance of oxygen concentrators in an effort to increase the availability management and quality of oxygen concentrators and ultimately to improve health outcomes in LRS. This document is intended to serve as a resource for the planning and provision of local and national oxygen concentrator systems for use by administrators clinicians and technicians who are interested in improving access to oxygen therapy and reducing global mortality associated with hypoxaemia.
Book Synopsis Principles of Biomedical Instrumentation by : Andrew G. Webb
Download or read book Principles of Biomedical Instrumentation written by Andrew G. Webb and published by Cambridge University Press. This book was released on 2018-01-11 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: This accessible yet in-depth textbook describes the step-by-step processes involved in biomedical device design. Integrating microfabrication techniques, sensors and digital signal processing with key clinical applications, it covers: the measurement, amplification and digitization of physiological signals, and the removal of interfering signals; the transmission of signals from implanted sensors through the body, and the issues surrounding the powering of these sensors; networks for transferring sensitive patient data to hospitals for continuous home-monitoring systems; tests for ensuring patient safety; the cost-benefit and technological trade-offs involved in device design; and current challenges in biomedical device design. With dedicated chapters on electrocardiography, digital hearing aids and mobile health, and including numerous end-of-chapter homework problems, online solutions and additional references for extended learning, it is the ideal resource for senior undergraduate students taking courses in biomedical instrumentation and clinical technology.
Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Book Synopsis Computer Safety, Reliability, and Security by : Francesca Saglietti
Download or read book Computer Safety, Reliability, and Security written by Francesca Saglietti and published by Springer Science & Business Media. This book was released on 2007-09-12 with total page 561 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 26th International Conference on Computer Safety, Reliability, and Security, SAFECOMP 2007. The 33 revised full papers and 16 short papers are organized in topical sections on safety cases, impact of security on safety, fault tree analysis, safety analysis, security aspects, verification and validation, platform reliability, reliability evaluation, formal methods, static code analysis, safety-related architectures.
Book Synopsis Medical Device Regulatory Practices by : Val Theisz
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Book Synopsis Distributed Computing and Monitoring Technologies for Older Patients by : Juris Klonovs
Download or read book Distributed Computing and Monitoring Technologies for Older Patients written by Juris Klonovs and published by Springer. This book was released on 2016-01-21 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book summarizes various approaches for the automatic detection of health threats to older patients at home living alone. The text begins by briefly describing those who would most benefit from healthcare supervision. The book then summarizes possible scenarios for monitoring an older patient at home, deriving the common functional requirements for monitoring technology. Next, the work identifies the state of the art of technological monitoring approaches that are practically applicable to geriatric patients. A survey is presented on a range of such interdisciplinary fields as smart homes, telemonitoring, ambient intelligence, ambient assisted living, gerontechnology, and aging-in-place technology. The book discusses relevant experimental studies, highlighting the application of sensor fusion, signal processing and machine learning techniques. Finally, the text discusses future challenges, offering a number of suggestions for further research directions.
Book Synopsis Foundations of Health Information Engineering and Systems by : Jeremy Gibbons
Download or read book Foundations of Health Information Engineering and Systems written by Jeremy Gibbons and published by Springer. This book was released on 2014-01-09 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed post-conference proceedings of the Third International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2013, held in Macau, China, in August 2013. The 19 revised full papers presented together with 1 invited talk in this volume were carefully reviewed and selected from 22 submissions. The papers are organized in following subjects: panel position statements, pathways, generation and certification, interoperability, patient safety, device safety, formal methods and HIV/AIDS and privacy.
