Test Method Validation for Medical Devices - Softcover

Tobin, Emmet

 
9781974211579: Test Method Validation for Medical Devices
Softcover
ISBN 10: 1974211576 ISBN 13: 9781974211579
Verlag: CreateSpace Independent Publishing Platform, 2017

Inhaltsangabe

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 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

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Verlag
CreateSpace Independent Publishing Platform
Erscheinungsdatum
2017
Sprache
Englisch
ISBN 10 
1974211576
ISBN 13 
9781974211579
Einband
Taschenbuch
Anzahl der Seiten
62
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
KreGa Onlinehandel GmbH
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info@krega-onlinehandel.de

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Brakel
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Deutschland