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Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer ,J?rg Schr?ttne Reference work 2023 Sprin

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書目名稱Medical Devices and In Vitro Diagnostics
副標題Requirements in Euro
編輯Christian Baumgartner,Johann Harer ,J?rg Schr?ttne
視頻videohttp://file.papertrans.cn/630/629149/629149.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 diagnostics, and
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 Reference work 2023 Sprin
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Reference work 2023
關(guān)鍵詞Quality management system for medical devices; Safety Requirements for MDR and IVD-R; GEP/GMP Complian
版次1
doihttps://doi.org/10.1007/978-3-031-22091-3
isbn_ebook978-3-031-22091-3Series ISSN 2731-0493 Series E-ISSN 2731-0507
issn_series 2731-0493
copyrightSpringer Nature Switzerland AG 2023
The information of publication is updating

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