Statistical Methods and Analyses for Medical Devices
Category: eBooks
- views: 88
- date: 11 May 2023
- posted by: AD-TEAM
pdf | 11.12 MB | English | Isbn: 978-3031261381 | Author: Scott A. Pardo | Year: 2023
Description:
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 medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example.
This book is for those with no statistical experience, as well as those with statistical knowledgeable―with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.
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 medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example.
This book is for those with no statistical experience, as well as those with statistical knowledgeable―with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.
Category:Mathematical & Statistical Software, Statistics, Probability & Statistics
We need your support!
Make a donation to help us stay online
Bitcoin (BTC)
bc1q08g9d22cxkawsjlf8etuek2pc9n2a3hs4cdrld
Bitcoin Cash (BCH)
qqvwexzhvgauxq2apgc4j0ewvcak6hh6lsnzmvtkem
Ethereum (ETH)
0xb55513D2c91A6e3c497621644ec99e206CDaf239
Litecoin (LTC)
ltc1qt6g2trfv9tjs4qj68sqc4uf0ukvc9jpnsyt59u
USDT (ERC20)
0xb55513D2c91A6e3c497621644ec99e206CDaf239
USDT (TRC20)
TYdPNrz7v1P9riWBWZ317oBgJueheGjATm
Information |
|||
 |
Users of GUESTS are not allowed to comment this publication. | ||