Validation of Final Test Equipment Specific to Medical Device

This paper presents the process of evaluating the capability of the testing process using the CMK and Cpk indices. This analysis starts by defining critical parameters and designating a golden sample unit. Data are collected and statistically analyzed in order to determine the variability and the degree of process centeredness with respect to the specified limits. CMK and Cpk indices are calculated and the results are interpreted according to the quality standards. The evaluation of the performance of the equipment consist of ambient pressure measurements and capability indices analyses. Thus, if the Cpk index doesn’t meet the imposed requirements, root causes are identified and corrective actions are implemented in order to monitoring the process in real time, to maintain stability and improve the performance of the test equipment.