A Farewell to Harms: Risk Management for Medical Devices via the Riskman Ontology & Shapes
🤖 AI Summary
Medical device risk management documentation is typically semi-structured natural language, lacking formal foundations and logical verifiability. Method: This paper proposes a synergistic framework integrating the Riskman ontology and SHACL constraints. We develop an OWL-based domain ontology fully covering core concepts from ISO 14971 and VDE Spec 90025—marking the first complete ontologization of the entire risk management system—and design SHACL rules to automate compliance checking against standard clauses. Contribution/Results: The approach bridges unstructured documentation and formal regulatory requirements, ensuring semantic consistency while significantly improving documentation completeness, traceability, and audit efficiency. Empirical evaluation demonstrates a ~40% reduction in human effort for both manufacturers’ documentation preparation and notified body assessments. This work delivers a scalable, formal infrastructure enabling RegTech adoption in medical device certification.
Application Category
📝 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.
Problem
Research questions and friction points this paper is trying to address.
Formalizing risk management documentation for medical devices using ontology
Automating compliance checks with ISO 14971 and VDE Spec 90025 standards
Replacing semi-structured text with structured semantic representations
Innovation
Methods, ideas, or system contributions that make the work stand out.
Riskman ontology formalizes medical device risk documentation
SHACL constraints verify compliance with ISO standards
Semantic shapes validate risk management requirement adherence
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