Test Method Validation for Medical Devices (Paperback) (ISBN-13: 9781974211579)

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

Author: Emmet Tobin
ISBN-10: 1974211576
ISBN-13: 9781974211579
Publisher: Createspace Independent Publishing Platform
Language: English
Published: 07/25/2017
Pages: 62
Format: Paperback
Weight: 0.16lbs
Size: 8.00h x 5.00w x 0.13d