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Test Method Validation for Medical Devices

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Big Data Analytics In M2M WHITE PAPER Test Method Validation for Medical Devices 2 | 2015, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. Table of Contents Abstract ........................................ ........................................ ............. 3 Abbreviations ........................................ ........................................ .... 3 Business challenge/needs ........................................ ......................... 3 Test Method Validation requirements ........................................ .... .4 TMV Implementation- Process Approach ........................................ . 7 HCL's Communication Governing Bridge ........................................ .. 9 Benefits of TMV Implementation and Integrated Approach.

for the gauge Analysis of reproducibility Day-to-day variability is assessed ... Precision (Repeatability) N/A Yes N/A Yes Precision (Intermediate) N/A Yes N/A Yes Specificity Yes Yes Yes Yes (LOD) Limit of Detection N/A Maybe Yes N/A …

  Gauge, Reproducibility, Repeatability

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