Concept for the testing of automated functions in therapeutic medical devices

Abstract In this paper, a testing for highly automated function (HAF) is adapted from the automotive industry to therapeutic medical devices. It contains different steps achieve safety argumentation: First, scenarios of interest (SoI) based on systematic generalization failure mode and effect analysis (FMEA) are identified, then concrete generated using design experiment (DoE). These simulated virtually physically evaluated. The procedure explained with use examples.