Management Of In Vitro Diagnostic Medical Devices
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Management of In Vitro Diagnostic Medical Devices
Author | : Medical Devices Agency |
Publsiher | : Unknown |
Total Pages | : 35 |
Release | : 2002 |
Genre | : Electronic Book |
ISBN | : 184182531X |
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Medical Devices and In Vitro Diagnostics
Author | : Christian Baumgartner,Johann Harer,Jörg Schröttner |
Publsiher | : Springer Nature |
Total Pages | : 671 |
Release | : 2023-08-26 |
Genre | : Technology & Engineering |
ISBN | : 9783031220913 |
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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.
Guideline for the Manufacture of in Vitro Diagnostic Products
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 48 |
Release | : 1990 |
Genre | : Diagnosis, Laboratory |
ISBN | : UOM:39015019576571 |
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Biodesign
Author | : Stefanos Zenios,Josh Makower,Paul Yock |
Publsiher | : Cambridge University Press |
Total Pages | : 779 |
Release | : 2010 |
Genre | : Medical |
ISBN | : 9780521517423 |
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Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
In Vitro Diagnostic Devices
Author | : Alfred Bracey |
Publsiher | : Unknown |
Total Pages | : 78 |
Release | : 1987 |
Genre | : Medical instruments and apparatus |
ISBN | : UCSD:31822017038282 |
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Guidance for post market surveillance and market surveillance of medical devices including in vitro diagnostics
Author | : Anonim |
Publsiher | : World Health Organization |
Total Pages | : 88 |
Release | : 2020-12-09 |
Genre | : Business & Economics |
ISBN | : 9789240015319 |
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First WHO Model List of Essential In Vitro Diagnostics
Author | : World Health Organization |
Publsiher | : World Health Organization |
Total Pages | : 73 |
Release | : 2019-05-16 |
Genre | : Medical |
ISBN | : 9789241210263 |
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The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries
Author | : United States. Bureau of Medical Devices and Diagnostic Products |
Publsiher | : Unknown |
Total Pages | : 24 |
Release | : 1976 |
Genre | : Medical instruments and apparatus |
ISBN | : UCR:31210023586173 |
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