Test Method Validation for Medical Devices

As defined by the Code of Federal Regulations Title 21, Part 820 – Quality System Regulation, Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can are fulfilled. Comparably, Test Method Validation (TMV) is the process of establishing the performance characteristics and limitations of a method and the identification of influences which may change these characteristics.

In some instances, validating methods is a regulatory requirement and an important element of quality control. Any time a new method is developed and validation methods are used in different test facilities, methods should be validated. This is especially true in the medical device market.

In Allan Marinelli's Test Method Validation Protocol outlines the program pertaining to each method in order to determine repeatability, reproducibility, accuracy, and reliability. 











System Owner/Data Owner










Validation or SME










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