Essential Principles of Safety and Effectiveness for Medical Devices, Shalinee Naidoo
Автор: Golombok Название: Regulating Reproductive Donation ISBN: 1107090962 ISBN-13(EAN): 9781107090965 Издательство: Cambridge Academ Рейтинг: Цена: 81310.00 T 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.
Автор: Shalinee Naidoo Название: How to Classify Your Medical Device Under European Regulations ISBN: 1774691876 ISBN-13(EAN): 9781774691878 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 189420.00 T Наличие на складе: Поставка под заказ. 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: Wiklund Michael, Davis Erin, Trombley Alexandria Название: User Interface Requirements for Medical Devices: Driving Toward Safe, Effective, and Satisfying Products by Specification ISBN: 0367457938 ISBN-13(EAN): 9780367457938 Издательство: Taylor&Francis Рейтинг: Цена: 188850.00 T 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.
Автор: Wong Jack, Tong Raymond K. Y. Название: Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products ISBN: 9814877867 ISBN-13(EAN): 9789814877862 Издательство: Taylor&Francis Рейтинг: Цена: 197010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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.
Автор: Wiklund, Michael, Название: User interface requirements for medical devices : ISBN: 0367457474 ISBN-13(EAN): 9780367457471 Издательство: Taylor&Francis Рейтинг: Цена: 74510.00 T 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.
Автор: Waldemar Wojcik Название: Information Technology in Medical Diagnostics ISBN: 1138299294 ISBN-13(EAN): 9781138299290 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T Наличие на складе: Невозможна поставка. Описание:
For many centuries, people have tried to learn about the state of their health. Initially, in the pre-technological period, they had to rely only on their senses. Then there were simple tools to help the human senses. The discovery of X-rays, which allowed people to look "inside" the body, turned out to be a major breakthrough. Contemporary medical diagnostics is increasingly being assisted by information technology that allows, for example, thorough image tissue analysis or pathology differentiation. They also allow very early preventive diagnostics. Influenced by information technology, "classic" diagnostic techniques change and new ones arise.
Information Technology in Medical Diagnostics presents selected and extended conference papers from Polish, Ukrainian and Kazakh scientists. They address problems of the application of new methods of image processing for analysis of medical images, new methods of classification of medical data as well as new medical imaging methods. Some of the presented technologies are inspired by the functioning of living organisms.
Information Technology in Medical Diagnostics is of interest not only to academics and engineers, but also to professionals involved in biomedical engineering, and seeking for solutions for issues that cannot be solved with the help of "traditional" technologies.
Автор: Justiniano Название: Six Sigma for Medical Devices Design. 2004 ISBN: 0849321050 ISBN-13(EAN): 9780849321054 Издательство: Taylor&Francis Рейтинг: Цена: 408320.00 T Наличие на складе: Невозможна поставка. Описание: Applies Six Sigma principles to the design of medical devices. This book provides a practical how-to guidance for implementation. It links the Six Sigma philosophy with the FDA`s Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control.
Автор: Shalinee Naidoo Название: A Beginners Road Map to the Medical Device Industry ISBN: 1774691566 ISBN-13(EAN): 9781774691564 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 189420.00 T Наличие на складе: Поставка под заказ. Описание: It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements between different countries means that a manufacturer's registration process becomes more complex and ultimately may require additional resources or information. This volume aims to provide a basic roadmap to beginners into the medical device industry. It provides a simplistic overview of the vast history behind much of the regulations and medical technology governing the field today as well as the need and importance of associated medical device regulations and essential principles governing safe and effective manufacture and use of these devices.
Автор: Shalinee Naidoo Название: Understanding the Role of Economic Operators Within the Medical Device Regulatory Sector ISBN: 1774690845 ISBN-13(EAN): 9781774690840 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 181110.00 T Наличие на складе: Поставка под заказ. 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: 334890.00 T 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.
Автор: Garima Srivastava; Manju Khari Название: Bioelectronics and Medical Devices ISBN: 1771889233 ISBN-13(EAN): 9781771889230 Издательство: Taylor&Francis Рейтинг: Цена: 141890.00 T 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.
Название: Progress in Ensuring Adequate Access to Internationally Controlled Substances for Medical and Scientific Purposes: Supplement to the Report of the Board for 2018 ISBN: 9211483107 ISBN-13(EAN): 9789211483109 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 21250.00 T Наличие на складе: Поставка под заказ. 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.
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