Guidelines for failure modes and effects analysis for medical devices
Auteur :
Press, Dyadem
Éditeur :
Taylor & Francis Inc
ISBN :
9780849319105
Date de publication :
3 mars 2003
Dimensions :
28,5 x 22,2 cm
Poids :
350 g
Langue :
Anglais
Pays d'origine :
USA
Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls.