Performance Evaluation and Clinical Performance report at M18

This report will be the second official Performance Evaluation and Clinical Performance report of the two products based on the methodology provided to the 136122002 for the IVD and the ISO 209162019 respectively More particularly these reports will verifyvalidate the Performance and Clinical Performance Methodology of the Clinical studies that the current project has followed the proper Regulatory roadmap for the validation accuracy and efficacy of the four products Furthermore this report will provide all the analysis of Data clinical documentation that will be collected during the validation studies summarized in one Report The updated report should be performed based on the design changes for the industrial manufacturing scaling up and should accompany the submission of the Technical Documentation of the four devices to the selected Notified Body