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Computational Regulation of Medical Devices in PSOA RuleML

  • Sofia AlmpaniEmail author
  • Petros Stefaneas
  • Harold Boley
  • Theodoros Mitsikas
  • Panayiotis Frangos
Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 11092)

Abstract

The registration and marketability of medical devices in Europe is governed by the Regulation (EU) 2017/745 and by guidelines published in terms thereof. This work focuses on formalizing the rules for risk-based classification of medical devices as well as the conformity assessment options for each class in Positional-Slotted Object-Applicative (PSOA) RuleML. We tested this open-source knowledge base by querying it in the open-source PSOATransRun system. The aim of this formalization is to create a computational guideline to assist stakeholders.

Notes

Acknowledgments

We thank Dr. Gen Zou (UNB) for realizing PSOATransRun and for his early comments on this work. Moreover, we thank Dr. Vasileios Aravantinos (Council of State of Greece) for his hints on the expressiveness, interpretability and accuracy of Medical Devices Rules.

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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Sofia Almpani
    • 1
    Email author
  • Petros Stefaneas
    • 2
  • Harold Boley
    • 3
  • Theodoros Mitsikas
    • 1
  • Panayiotis Frangos
    • 1
  1. 1.School of Electrical and Computer EngineeringNational Technical University of AthensAthensGreece
  2. 2.School of Applied MathematicsNational Technical University of AthensAthensGreece
  3. 3.Faculty of Computer ScienceUniversity of New BrunswickFrederictonCanada

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