The 'How' and 'Why' of Test Method Validation.

The article discusses the importance of test method validation (TMV) in the quality control process of medical device manufacturers. Topics include the challenges in demonstrating the safety and effectiveness of medical devices, the key experiments involved in TMV, and process validation guidance of the U.S. Food and Drug Administration (FDA). Also offered are the key characteristics of TMV which include the accuracy, reproducibility, and robustness.