Essential Principles of Safety and Effectiveness for Medical Devices, Shalinee Naidoo
Автор: Wiklund, Michael, Название: User interface requirements for medical devices : ISBN: 0367457474 ISBN-13(EAN): 9780367457471 Издательство: Taylor&Francis Рейтинг: Цена: 11176.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths.
Описание: Over the last 20 or so years, the number, range, and complexity of medical devices available on the market has increased drastically and as a result, so has the complexity of the regulations involved. With new and emerging technologies as well as various well-known incidents within the medical device industry, the current regulatory framework has since been challenged. In fact, many gaps and scarcity of skills and expertise have been identified. For this reason, there was an increasing need to update the current Medical Device Directive (MDD 93/42/EEC) in the European Union, which in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe with specific focus on classification methods. It looks specifically at how to class a medical device based on the risk associated with it as well the details around the European Classification Systems provided in the MEDDEV 2.4/1. This volume also delves into the detail around defining borderline medical devices and how they are classified according to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices as published by the European Commission.
Автор: Garima Srivastava; Manju Khari Название: Bioelectronics and Medical Devices ISBN: 1771889233 ISBN-13(EAN): 9781771889230 Издательство: Taylor&Francis Рейтинг: Цена: 21284.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Bioelectronics and Medical Devices: Applications and Technology provides an abundance of information on new applications being used today for biomedical applications. The book covers a wide range of concepts and technologies used in biomedical applications, discussing such modern technological methods.
Автор: Golombok Название: Regulating Reproductive Donation ISBN: 1107090962 ISBN-13(EAN): 9781107090965 Издательство: Cambridge Academ Рейтинг: Цена: 12197.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The emergence of new empirical evidence and ethical debate has called into question the current regulatory frameworks that govern reproductive donation, both in the UK and overseas. In response, this book offers fresh interdisciplinary perspectives on current challenges facing the regulation of reproductive donation, and suggests possible ways forward.
Описание: New and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework, highlighted gaps and pointed to a certain scarcity of skills and expertise. For this reason, there was increasing need to update the European Medical Device Directives. This has since led to the development and release of the Medical Device Regulation (MDR 2017/745) which has now put stricter regulatory controls on the entire product life cycle. Both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) contain a complete section on economic operators for medical devices. Although the manufacturer is ultimately responsible for ensuring their medical device is compliant with the relevant legislation, the various defined economic operators within the Regulation, now have a part to play in ensuring the safety and performance of the device throughout the supply chain. This new policy of sharing compliance is an important component of the MDR2017/745 with each economic operator serving as a control on the other, causing each device to receive a number of checks throughout the process before it is brought to market. In addition to this, it also allows for any compliance issues emerging from any one of the economic operators to have a direct legal implication on the other. Changes brought about by the MDR2017/745 in Europe require not only manufacturers but all defined economic operators to take a proactive, multilevel and multidisciplinary approach when it comes to ensuring safe and effective devices are placed on the market. This volume looks at each Economic Operator in greater details with their relevant responsibilities.
Автор: Feldschreiber Peter Название: The Law and Regulation of Medicines and Medical Devices ISBN: 0192847546 ISBN-13(EAN): 9780192847546 Издательство: Oxford Academ Рейтинг: Цена: 50233.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.
Описание: This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths.
Описание: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application.
Описание: The preamble of the Single Convention of 1961 highlights the concern of States for the health and welfare of humankind. This assertion is followed by the recognition of the medical use of narcotic drugs and their indispensable role in the relief of pain for which countries needed to ensure the availability and to make adequate provision.
Автор: Fries Название: Reliable Design of Medical Devices ISBN: 1138075191 ISBN-13(EAN): 9781138075191 Издательство: Taylor&Francis Рейтинг: Цена: 15312.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.
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