Supporting Risk Management for Medical Devices via the Riskman Ontology and Shapes (Preprint)
This work addresses the challenge of semi-structured risk management documentation for medical device certification, offering a formalized approach to improve compliance and safety.
The authors tackled the problem of managing risk documentation for medical devices by proposing the Riskman ontology and SHACL shapes to formalize and analyze this information, enabling automated compliance checks with ISO 14971 and VDE Spec 90025 standards.
We propose the Riskman ontology and shapes for representing and analysing information about risk management for medical devices. Risk management is concerned with taking necessary precautions to ensure that 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 terms from the Riskman ontology to provide a formal, logical underpinning for risk management documentation, and to use the included SHACL constraints to check whether the provided data is in accordance with the requirements of the two relevant norms, i.e. ISO 14971 and VDE Spec 90025.