Test Method Validation for Medical Devices - Brossura

Tobin, Emmet

 
9781974211579: Test Method Validation for Medical Devices
Brossura
ISBN 10: 1974211576 ISBN 13: 9781974211579
Casa editrice: CreateSpace Independent Publishing Platform, 2017

Sinossi

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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Editore
CreateSpace Independent Publishing Platform
Data di pubblicazione
2017
Lingua
Inglese
ISBN 10 
1974211576
ISBN 13 
9781974211579
Rilegatura
Copertina flessibile
Numero di pagine
62
Contatto del produttore
Manufactured by Amazon on behalf of the author
https://www.amazon.it/hz/contact-us

c/o Amazon Media EU S.à.r.l., 38 Avenue John F. Kennedy
Luxembourg
L-1855
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