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Test Method Validation for Medical Devices by Emmet Tobin (2017, Trade Paperback)
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TEST METHOD VALIDATION FOR MEDICAL DEVICES By Emmet Tobin **BRAND NEW**.
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About this product
Product Identifiers
PublisherCreateSpace
ISBN-101974211576
ISBN-139781974211579
eBay Product ID (ePID)242611991
Product Key Features
Book TitleTest Method Validation for Medical Devices
Number of Pages62 Pages
LanguageEnglish
Publication Year2017
TopicBiomedical
GenreTechnology & Engineering
AuthorEmmet Tobin
FormatTrade Paperback
Dimensions
Item Height0.1 in
Item Weight4.2 Oz
Item Length8 in
Item Width5 in
Additional Product Features
Intended AudienceTrade
SynopsisThis concise book fits right in the Engineers pocket. It provides a brief introduction to Test method validation and is a useful resource that defines key terms and concepts. The following points are addressed: Examples of Test Method ValidationsWhat is test method validation?Why should TMV be performed?When should methods be validated?Regulatory Overview US Food and Drug AdministrationW.H.OISO 13485Definitions and Key Concepts New Test MethodsChanges to Existing MethodsAccuracyPrecisionRuggednessRepresentative/Continuous Sampling RangeResolutionProbability Of False Alarms P (Fa)Probability Of Misses P (M)Validation Protocols What Can Impact the Accuracy of a Test Method? General MSA requirements Variable MSA Studies Attribute MSA Studies Measurement Capability Index, This concise book fits right in the Engineers pocket. It provides a brief introduction to Test method validation and is a useful resource that defines key terms and concepts. The following points are addressed: Examples of Test Method Validations What is test method validation? Why should TMV be performed? When should methods be validated? Regulatory Overview US Food and Drug Administration W.H.O ISO 13485 Definitions and Key Concepts New Test Methods Changes to Existing Methods Accuracy Precision Ruggedness Representative/Continuous Sampling Range Resolution Probability Of False Alarms P (Fa) Probability Of Misses P (M) Validation Protocols What Can Impact the Accuracy of a Test Method? General MSA requirements Variable MSA Studies Attribute MSA Studies Measurement Capability Index
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