Guidelines for failure modes and effects analysis for medical devices
Auteur :
Press, Dyadem
Éditeur :
Taylor & Francis Ltd
ISBN :
9781138464100
Date de publication :
28 juin 2018
Dimensions :
28,0 x 21,0 cm
Poids :
360 g
Langue :
Anglais
Pays d'origine :
Grande Bretagne
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.