TY - BOOK
T1 - Medical Devices and In Vitro Diagnostics
T2 - Requirements in Europe
A2 - Baumgartner, Christian
A2 - Harer, Johann
A2 - Schröttner, Jörg
PY - 2023/8/27
Y1 - 2023/8/27
N2 - 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 medical students who are preparing themselves for a professional career in the medical technlogy industries
AB - 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 medical students who are preparing themselves for a professional career in the medical technlogy industries
U2 - 10.1007/978-3-031-22091-3
DO - 10.1007/978-3-031-22091-3
M3 - Anthology
SN - 978-3-031-22090-6
T3 - Reference Series in Biomedical Engineering
BT - Medical Devices and In Vitro Diagnostics
PB - Springer Nature Switzerland AG
CY - Cham
ER -