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

Piotr GorczycaPiotr Gorczyca, Dörthe ArndtDörthe Arndt, Martin DillerMartin Diller, Jochen HampeJochen Hampe, Georg HeidenreichGeorg Heidenreich, Pascal KettmannPascal Kettmann, Markus KrötzschMarkus Krötzsch, Stephan MennickeStephan Mennicke, Sebastian RudolphSebastian Rudolph, Hannes StraßHannes Straß

Piotr Gorczyca, Dörthe Arndt, Martin Diller, Jochen Hampe, Georg Heidenreich, Pascal Kettmann, Markus Krötzsch, Stephan Mennicke, Sebastian Rudolph, Hannes Straß
Supporting Risk Management for Medical Devices via the Riskman Ontology and Shapes
Proceedings of the 21st International Conference on Semantic Systems (SEMANTiCS 2025), to appear

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Bibtex

KurzfassungAbstract
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.
Projekt:Project: KIMEDS, MEDGE, SEMECO-Q2
Forschungsgruppe:Research Group: Computational LogicComputational Logic, Logische Programmierung und ArgumentationLogic Programming and Argumentation, Wissensbasierte SystemeKnowledge-Based Systems

@inproceedings{GADHHKKMRS2025,
  author    = {Piotr Gorczyca and D{\"{o}}rthe Arndt and Martin Diller and
               Jochen Hampe and Georg Heidenreich and Pascal Kettmann and Markus
               Kr{\"{o}}tzsch and Stephan Mennicke and Sebastian Rudolph and
               Hannes Stra{\ss}},
  title     = {Supporting Risk Management for Medical Devices via the Riskman
               Ontology and Shapes},
  booktitle = {Proceedings of the 21st International Conference on Semantic
               Systems (SEMANTiCS 2025)},
  year      = {2025},
  month     = {September}
}

Access the live presentation at https://gorczyca.github.io/semantics-25-slides/