Medical Devices and In Vitro Diagnostics
Requirements in Europe
Buch in deiner Nähe kaufen
Beschreibung
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.
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 software devices
Autor*in
Christian Baumgartner
Themen in »Medical Devices and In Vitro Diagnostics«
Quality management system for medical devices Safety Requirements for MDR and IVD-R GEP/GMP Compliance EU IVD-R EU MDR EU 2017/745 EU 2017/746 EU Notified Bodies for Medical Devices Post-market Surveillance of Medical Devices Risk Management for Medical Devices Software as medical device (SaMD)