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Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer ,J?rg Schr?ttne Living reference work 202

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發(fā)表于 2025-3-21 16:39:54 | 只看該作者 |倒序?yàn)g覽 |閱讀模式
書目名稱Medical Devices and In Vitro Diagnostics
副標(biāo)題Requirements in Euro
編輯Christian Baumgartner,Johann Harer ,J?rg Schr?ttne
視頻videohttp://file.papertrans.cn/630/629150/629150.mp4
概述Covers the latest EU regulatory requirements and standards for developing medical devices.Includes information on patents and licenses.Covers regulations for medical devices, In-vitro diagnostic produ
叢書名稱Reference Series in Biomedical Engineering
圖書封面Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer	,J?rg Schr?ttne Living reference work 202
描述.This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe.?These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in?development, production, and quality assurance departments, and?technical and medicalstudents who are preparing themselves for a professional career in the medical technlogy industries.?.
出版日期Living reference work 20220th edition
關(guān)鍵詞Quality management system for medical devices; Safety Requirements for MDR and IVD-R; GEP/GMP Complian
doihttps://doi.org/10.1007/978-3-030-98743-5
isbn_ebook978-3-030-98743-5
issn_series 2731-0493
The information of publication is updating

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發(fā)表于 2025-3-22 00:10:45 | 只看該作者
The Notified Body: The Conformity Assessment Body for Medical Devices in Europe,ter, we present in detail what a Notified Body is in the sense of the aforementioned regulations and what special requirements are placed on designated notified bodies. We describe when a Notified Body is required for CE marking and what the main tasks of a Notified Body are in the conformity assess
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Safety Requirements for Medical Devices in Compliance with European Standards,es to comply with the state of the art and how it can be achieved. It also provides a brief overview of the safety requirements of the medical device regulations, with a focus on single fault conditions and the philosophy of integrated safety, together with an attempt to identify possible ways of pr
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Risk Management for Medical Devices in Compliance with EN ISO 14971,its implementation is outlined. In addition, the individual elements of the risk management process are described and discussed in detail. All documents that are considered as evidence of the establishment of a complete risk management process are presented, and their necessary content is shown. The
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發(fā)表于 2025-3-22 21:24:31 | 只看該作者
Medical Products: Packing and Labeling Requirements, practice. Other legislation, such as CLP and transport of hazardous materials, may apply and have to be considered as well. It has further become common practice that the manufacturer will consider providing information on safe or environmentally responsible disposal of packaging.
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