Statistical Methods and Analyses for Medical Devices : Springer : 9783031261381 : 3031261380 : 25 Apr 2023 : This book provides a reference for people working in the design, development, and manufacturing of medical devices. ?While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes. While, there are no statistical methods specifically designed for analysis of medical device data, there are some methods that seem to appear regularly in relation to medica