TY - BOOK ID - 119431053 TI - Medical Devices and In Vitro Diagnostics : Requirements in Europe AU - Baumgartner, Christian. AU - Harer, Johann. AU - Schröttner, Jörg. PY - 2023 SN - 3031220919 PB - Cham : Springer International Publishing : Imprint: Springer, DB - UniCat KW - Biomedical engineering. KW - Industrial Management. KW - Technological innovations. KW - Biomedical Devices and Instrumentation. KW - Innovation and Technology Management. KW - Breakthroughs, Technological KW - Innovations, Industrial KW - Innovations, Technological KW - Technical innovations KW - Technological breakthroughs KW - Technological change KW - Creative ability in technology KW - Inventions KW - Domestication of technology KW - Innovation relay centers KW - Research, Industrial KW - Technology transfer KW - Business administration KW - Business enterprises KW - Business management KW - Corporate management KW - Corporations KW - Industrial administration KW - Management, Industrial KW - Rationalization of industry KW - Scientific management KW - Management KW - Business KW - Industrial organization KW - Clinical engineering KW - Medical engineering KW - Bioengineering KW - Biophysics KW - Engineering KW - Medicine UR - https://www.unicat.be/uniCat?func=search&query=sysid:119431053 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. . ER -