Name: Medical Devices and in Vitro Diagnostics: Requirements in Europe (en Inglés)
Price: 1224.05 PEN
Availability: InStock
Author: Baumgartner, Christian ; Harer, Johann ; Schröttner, Jörg
ISBN: 9783031220906

portada Medical Devices and in Vitro Diagnostics: Requirements in Europe (en Inglés)

Medical Devices and in Vitro Diagnostics: Requirements in Europe (en Inglés)

Formato

Libro Físico

Editorial

Springer

Autor

Baumgartner, Christian ; Harer, Johann ; Schröttner, Jörg

Idioma

Inglés

N° páginas

665

Encuadernación

Tapa Dura

Dimensiones

23.8 x 16.0 x 4.0 cm

Peso

1.32 kg.

ISBN13

9783031220906

Categorías

Gestión y técnicas de gestión
Ingeniería biomédica
Biotecnología

Medical Devices and in Vitro Diagnostics: Requirements in Europe (en Inglés)

Baumgartner, Christian ; Harer, Johann ; Schröttner, Jörg (Autor) · Springer · Tapa Dura

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Reseña del libro "Medical Devices and in Vitro Diagnostics: Requirements in Europe (en Inglés)"

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.