Performance Evaluation of in Vitro Diagnostic Medical Devices
Title | Performance Evaluation of in Vitro Diagnostic Medical Devices PDF eBook |
Author | British Standards Institute Staff |
Publisher | |
Pages | 18 |
Release | 2002-05-07 |
Genre | |
ISBN | 9780580396502 |
Medical equipment, Performance testing, Clinical investigation instruments, Diagnosis (medical), Patients, Diagnostic testing
BS EN 13612:2002
Title | BS EN 13612:2002 PDF eBook |
Author | British Standards Institution |
Publisher | |
Pages | 15 |
Release | 2002 |
Genre | |
ISBN |
Performance Evaluation of in Vitro Diagnostic Medical Devices
Title | Performance Evaluation of in Vitro Diagnostic Medical Devices PDF eBook |
Author | Malaysia. Jabatan Standard |
Publisher | |
Pages | 15 |
Release | 2010 |
Genre | Medical instruments and apparatus |
ISBN |
UNE-EN 13612:2002
Title | UNE-EN 13612:2002 PDF eBook |
Author | |
Publisher | |
Pages | 18 |
Release | 2018 |
Genre | |
ISBN |
UNE-EN 13612/AC:2003
Title | UNE-EN 13612/AC:2003 PDF eBook |
Author | |
Publisher | |
Pages | 6 |
Release | 2018 |
Genre | |
ISBN |
Medical Devices and In Vitro Diagnostics
Title | Medical Devices and In Vitro Diagnostics PDF eBook |
Author | Christian Baumgartner |
Publisher | Springer Nature |
Pages | 671 |
Release | 2023-08-26 |
Genre | Technology & Engineering |
ISBN | 3031220919 |
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.
The assessment process for listing of performance evaluation laboratories in connection with WHO prequalification of in vitro diagnostics
Title | The assessment process for listing of performance evaluation laboratories in connection with WHO prequalification of in vitro diagnostics PDF eBook |
Author | World Health Organization |
Publisher | World Health Organization |
Pages | 32 |
Release | 2024-02-07 |
Genre | Medical |
ISBN | 9240078258 |