Abstract: Mechanisms are provided for automated medical device regulation risk analysis (MDRRA). An automated MDRRA engine receives compliance rules for a medical device, a data dictionary for a patient data source, and medical device characteristics data for the medical device. The automated MDRRA engine automatically determines, based on the compliance rules and the data dictionary, critical fields of patient data and medical device characteristics data for demonstrating medical device efficacy according to the compliance rules. The automated MDRRA engine automatically determines, based on the critical fields, one or more patient population data subsets for a plurality of patients from a patient population data set and selects a population segment from the one or more patient population data sets to populate an electronic case report form (eCRF) study build. The automated MDRRA engine automatically populates fields of the eCRF with data from the population data sets corresponding to the selected population segment.