Supporting Risk Management for Medical Devices via the Riskman Ontology and Shapes (Preprint)

TL;DR

This paper introduces the Riskman ontology and shape constraints to formalize and validate risk management documentation for medical devices, ensuring compliance with relevant standards.

Contribution

It presents a novel ontology and SHACL shapes for formalizing and validating risk management data in medical device regulation.

Findings

Ontology enables formal representation of risk management info

SHACL shapes facilitate compliance checking

Supports automated validation against ISO 14971 and VDE standards

Abstract

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.