Books by Michael Wiklund

This book offers practical guidance on how to methodically discover and explain the root cause of a use error¿a mistake¿that occurs when someone uses a medical device. From home-use products to devices used in clinical environments, the text presents case studies that show how root cause analysis leads from understanding a use error¿s causes and consequences to the development of design-based preventions. Using clear illustrations and simple narrative explanations, the text covers the fundamentals, language, and regulatory expectations of root cause analysis.