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

arXiv: https://arxiv.org/abs/2405.09875 · HTML: https://mlsanity.com/paper/2405.09875/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 5 of its 72 references that are in the map.
- First posted on arXiv 16 May 2024.

## Builds on (most cited first, 5 of 5)

- [How to Agree to Disagree: Managing Ontological Perspectives using Standpoint Logic](https://mlsanity.com/paper/2206.06793/) (2022)
- [SHACL Constraints with Inference Rules](https://mlsanity.com/paper/1911.00598/) (2019)
- [Tractable Diversity: Scalable Multiperspective Ontology Management via Standpoint EL](https://mlsanity.com/paper/2302.13187/) (2023)
- [Integration of Formal Proof into Unified Assurance Cases with Isabelle/SACM](https://mlsanity.com/paper/2009.12154/) (2020)
- [Pushing the Boundaries of Tractable Multiperspective Reasoning: A Deduction Calculus for Standpoint EL+](https://mlsanity.com/paper/2304.14323/) (2023)

## Abstract (arXiv)

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.