Test Method Validation for Medical Devices - Couverture souple

Tobin, Emmet

 
9781974211579: Test Method Validation for Medical Devices
Couverture souple
ISBN 10 : 1974211576 ISBN 13 : 9781974211579
Editeur : CreateSpace Independent Publishing Platform, 2017

Synopsis

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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Éditeur
CreateSpace Independent Publishing Platform
Date d'édition
2017
Langue
anglais
ISBN 10 
1974211576
ISBN 13 
9781974211579
Reliure
Broché
Nombre de pages
62
Coordonnées du fabricant
non disponible
Personne responsable
non disponible