Mastering Safety Risk Management for Medical and In Vitro Devices - Brossura

Moon, Jayet; Mathew, Arun

 
9781636941707: Mastering Safety Risk Management for Medical and In Vitro Devices
Brossura
ISBN 10: 1636941702 ISBN 13: 9781636941707
Casa editrice: ASQ Quality Press, 2024

Sinossi

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

Editore
ASQ Quality Press
Data di pubblicazione
2024
Lingua
Inglese
ISBN 10 
1636941702
ISBN 13 
9781636941707
Rilegatura
Copertina flessibile
Numero di pagine
306
Contatto del produttore
non disponibile
Persona responsabile
gpsr@libri.de
gpsr@libri.de

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