Transcription of Test Method Validation for Medical Devices
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Test Method Validation for Medical Devices
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 .. 10 Conclusion .. 10 References ..11 Author Info .. 12 3 | 2015, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved. Abstract tests or Inspections are defined as the process of verifying the manufactured product for any defects and conformance to its intended functions. Test methods are the set of procedures defined to execute the tests . Test Method Validation means establishing by objective, evidence that the test Method consistently produces a desired result required to satisfy the intended use.
for Test Method Validation has been applied to chemical and to microbial acceptance test method. However, regulatory expectation was evidenced by warning letters dating back to at least 2005, indicating that method validation is an applicable medical device validation activity for both physical and chemical test method.
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