Medical Devices and In Vitro Diagnostics: Requirements in Europe (1st ed. 2023) (Reference Series in Biomedical Engineering)

By: Christian Baumgartner and Johann Harer and Jörg Schröttner

Sign Up Now! Already a Member? Log In
You must be logged into Bookshare to access this title. Learn about membership options, or view our freely available titles.

Synopsis: 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.

Book Quality:: Publisher Quality
ISBN-13:: 9783031220913
Related ISBNs:: 9783031220906
Publisher:: Springer International Publishing
Date of Addition:: 09/27/23
Copyrighted By:: Springer Nature Switzerland AG
Adult content:: No
Language:: English
Has Image Descriptions:: No
Categories:: Nonfiction, Science, Business and Finance, Technology, Medicine
Submitted By:: Bookshare Staff
Usage Restrictions:: This is a copyrighted book.
Edited by:: Christian Baumgartner
Edited by:: Johann Harer
Edited by:: Jörg Schröttner