Summary of A Farewell to Harms: Risk Management For Medical Devices Via the Riskman Ontology & Shapes, by Piotr Gorczyca et al.
A Farewell to Harms: Risk Management for Medical Devices via the Riskman Ontology & Shapes
by Piotr Gorczyca, Dörthe Arndt, Martin Diller, Pascal Kettmann, Stephan Mennicke, Hannes Strass
First submitted to arxiv on: 16 May 2024
Categories
- Main: Artificial Intelligence (cs.AI)
- Secondary: Computers and Society (cs.CY)
GrooveSquid.com Paper Summaries
GrooveSquid.com’s goal is to make artificial intelligence research accessible by summarizing AI papers in simpler terms. Each summary below covers the same AI paper, written at different levels of difficulty. The medium difficulty and low difficulty versions are original summaries written by GrooveSquid.com, while the high difficulty version is the paper’s original abstract. Feel free to learn from the version that suits you best!
| Summary difficulty | Written by | Summary |
|---|---|---|
| High | Paper authors | High Difficulty Summary Read the original abstract here |
| Medium | GrooveSquid.com (original content) | Medium Difficulty Summary The proposed Riskman ontology and shapes aim to standardize the representation and analysis of risk management information for medical devices. By using classes from the Riskman ontology to logically model risk management documentation, and SHACL constraints to ensure syntactic completeness and conformity to relevant standards, manufacturers and notified bodies can reduce the time spent on creating and assessing risk management applications. The methodology is based on ISO 14971 and VDE Spec 90025 guidelines. |
| Low | GrooveSquid.com (original content) | Low Difficulty Summary The Riskman ontology and shapes are designed to improve the risk management process for medical devices. By using a standardized approach, manufacturers and notified bodies can create and analyze risk management documentation more efficiently. This could lead to significant time savings and benefits for healthcare and society as a whole. |
