The Law and Regulation of Medicines and Medical Devices, Feldschreiber Peter
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: 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: 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: Matthew W Hill, Daniel E Torres Название: FDA Oversight of Medical Devices: Efforts & Developments ISBN: 1622570898 ISBN-13(EAN): 9781622570898 Издательство: Nova Science Рейтинг: Цена: 168950.00 T Наличие на складе: Невозможна поставка. Описание: The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.
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.
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: Shalinee Naidoo Название: Essential Principles of Safety and Effectiveness for Medical Devices ISBN: 177469185X ISBN-13(EAN): 9781774691854 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 189420.00 T Наличие на складе: Поставка под заказ. Описание: The medical device sector is growing fast. Every day new technology which is both complex and smart are being added to the industry. Ensuring safe and effective use of medical devices for patients and users of the device itself is a crucial responsibility for manufacturers. When designing and manufacturing medical devices, safety, and efficacy should be of utmost importance. A manufacturer should never compromise on the clinical safety requirements of its users, patients or any other persons involved. Generally, the design of a medical device is regulated by the essential principles (EP) of safety and performance. What this means is that if a device is designed to relieve pain, the manufacturer must be able to clinically prove that the device can in fact relieve pain. Often this poses a great deal of challenges to manufacturers; however, building in appropriate safety and risk management functions across a device's lifecycle is imperative if they wish to reduce the risk of post-market problems. This volume aims to provide an overview of the harmonized essential principles that must be achieved in the design and development of medical devices. It provides an in-depth explanation of the relevant medical device regulations in Europe with a specific focus on the safety and performance requirements for medical devices.
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: Cohen, I. Glenn Название: Future of medical device regulation ISBN: 1108972055 ISBN-13(EAN): 9781108972055 Издательство: Cambridge Academ Рейтинг: Цена: 36950.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: As the nature of medical devices is rapidly changing, the legal and ethical questions around medical devices are becoming ever more complex. This volume analyses the current issues and controversies around patient privacy, innovation, and new regulatory laws in the US and EU.
Автор: Cohen I. Glenn, Minssen Timo, Price II W. Nicholson Название: The Future of Medical Device Regulation: Innovation and Protection ISBN: 1108838634 ISBN-13(EAN): 9781108838634 Издательство: Cambridge University Press Рейтинг: Цена: 173270.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: As the nature of medical devices is rapidly changing, the legal and ethical questions around medical devices are becoming ever more complex. This volume analyses the current issues and controversies around patient privacy, innovation, and new regulatory laws in the US and EU.
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.
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