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Test Method Validation for Medical Devices - Tapa blanda

Tobin, Emmet

 
9781974211579: Test Method Validation for Medical Devices
Tapa blanda
ISBN 10: 1974211576 ISBN 13: 9781974211579
Editorial: CreateSpace Independent Publishing Platform, 2017

Sinopsis

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

"Sinopsis" puede pertenecer a otra edición de este libro.

Editorial
CreateSpace Independent Publishing Platform
Año de publicación
2017
Idioma
Inglés
ISBN 10 
1974211576
ISBN 13 
9781974211579
Encuadernación
Tapa blanda
Número de páginas
62
Contacto del fabricante
Manufactured by Amazon on behalf of the author
https://www.amazon.es/hz/contact-us

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