| 书目名称 | Medical Devices and In Vitro Diagnostics | | 副标题 | Requirements in Euro | | 编辑 | Christian Baumgartner,Johann Harer ,Jörg Schröttne | | 视频video | | | 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 | | 丛书名称 | Reference Series in Biomedical Engineering | | 图书封面 |  | | 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 | | 关键词 | Quality management system for medical devices; Safety Requirements for MDR and IVD-R; GEP/GMP Complian | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-031-22091-3 | | isbn_ebook | 978-3-031-22091-3Series ISSN 2731-0493 Series E-ISSN 2731-0507 | | issn_series | 2731-0493 | | copyright | Springer Nature Switzerland AG 2023 |
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发表于 2025-3-21 17:36:20
