| Test Method Validation for Medical Devices Contributor(s): Tobin, Emmet (Author) |
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ISBN: 1974211576 ISBN-13: 9781974211579 Publisher: Createspace Independent Publishing Platform OUR PRICE: $21.84 Product Type: Paperback Published: July 2017 |
| Additional Information |
| BISAC Categories: - Technology & Engineering | Biomedical - Technology & Engineering | Materials Science - General |
| Physical Information: 0.13" H x 5" W x 8" (0.16 lbs) 62 pages |
| Descriptions, Reviews, Etc. |
| Publisher 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 |