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

Moon, Jayet; Mathew, Arun

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

Inhaltsangabe

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).

Die Inhaltsangabe kann sich auf eine andere Ausgabe dieses Titels beziehen.

Verlag
ASQ Quality Press
Erscheinungsdatum
2024
Sprache
Englisch
ISBN 10 
1636941702
ISBN 13 
9781636941707
Einband
Taschenbuch
Anzahl der Seiten
306
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
gpsr@libri.de
gpsr@libri.de

Friedensallee 273
Hamburg
22763
Deutschland