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Test Method Validation for Medical Devices

by Test Method Validation for Medical Devices

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Description

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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Product Details

  • CreateSpace Independent P Brand
  • Jul 25, 2017 Pub Date:
  • 9781974211579 ISBN-13:
  • 1974211576 ISBN-10:
  • English Language
  • 8 in * 0.14 in * 5 in Dimensions:
  • 0 lb Weight: