Evaluation of the destructive test in medical devices manufacturing

Testing the quality of produced medical devices is undoubtedly a crucial issue. If a product of compromised quality is sold, it would first of all have an impact on the health of patients and, consequently, on the economic performance of the manufacturer. Destructive testing of medical devices is expensive and there are attempts to replace it by non-destructive tests. During the substitution of destructive tests with non-destructive ones, the strength of the test should be rationalized at the stage of process control planning. To do so, logit or probit models are the first choice. This article deals with an evaluation of typical destructive test results from both product and process verification and validation of medical devices. The differences between the estimated logit and probit models are discussed and arguments when to prefer which one are collected. Finally, replacement of destructive testing by non-destructive testing is evaluated numerically.