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.
medical device test method validation may result in product recalls and negative financial impacts. The present and future market scenario has a clear defined objective of projecting quality as the sole weapon for every medical device manufacturer to survive. Test method validation remains a crucial role in ensuring the medical device validation.
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