  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.
