As already mentioned above, the following applies to the Clinical Evaluation as part of the technical documentation: After placing the product on the market, the work is not yet finally completed. As a manufacturer, you are obliged to constantly update new findings and results, because the Clinical Evaluation is part of the post-market clinical follow-up (PMCF).
Software solutions are recommended so that you can seamlessly maintain your Clinical Evaluation documentation throughout the entire life cycle of your medical device. By digitising this process, you reduce workload and keep your assessments consistent and unambiguous, as your data and analyses are updated centrally in one place. In addition, you can use existing information, e.g. the Essential Safety and Performance Requirements, for your assessment report.