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Test Method Validation for Medical Devices - Emmet Tobin

inglise keel
2017-07-25
24,35 € 40,58 €

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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 Validations What is test method validation? Why should TMV be performed? When should methods be validated? Regulatory Overview US Food and Drug Administration W.H.O ISO 13485 ... Täielik kirjeldus

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Kirjeldus

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 Validations What is test method validation? Why should TMV be performed? When should methods be validated? Regulatory Overview US Food and Drug Administration W.H.O ISO 13485 Definitions and Key Concepts New Test Methods Changes to Existing Methods Accuracy Precision Ruggedness Representative/Continuous Sampling Range Resolution Probability 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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Autor Emmet Tobin
Kirjastaja CreateSpace Independent Publishing Platform
Väljalaskeaasta 2017
Kaanetüüp Pehme kaanega
EAN 9781974211579
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24,35 € 40,58 €