Title: A Farewell to Harms: Risk Management for Medical Devices via the Riskman Ontology & Shapes

Abstract: We introduce the Riskman ontology & shapes for representing and analysing information about risk management for medical devices. Risk management is concerned with taking necessary precautions so a medical device does not cause harms for users or the environment. To date, risk management documentation is submitted to notified bodies (for certification) in the form of semi-structured natural language text. We propose to use classes from the Riskman ontology to logically model risk management documentation and to use the included SHACL constraints to check for syntactic completeness and conformity to relevant standards. In particular, the ontology is modelled after ISO 14971 and the recently published VDE Spec 90025. Our proposed methodology has the potential to save many person-hours for both manufacturers (when creating risk management documentation) as well as notified bodies (when assessing submitted applications for certification), and thus offers considerable benefits for healthcare and, by extension, society as a whole.