Towards a logic-based extension of a relational software tool for coherent technical documentation of medical devices

Tobias Lueddemann, Jonas Schiebl, Daniel Roppenecker, Franziska Klein, Tim C. Lueth

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

2 Scopus citations

Abstract

This work presents a novel software tool intended to support compilation of coherent technical documentation. It is based on a relational database system serving as knowledge base incorporating information from the European Medical Device Directive and harmonized standards such as ISO 14971, ISO 980 or ISO 10993-x. In order to achieve increased consistency among sections of documentation for medical devices a concept for formal description of technical documentation and an additional logic-based system is presented.

Original languageEnglish
Title of host publicationISPCE 2015 - IEEE Symposium on Product Compliance Engineering, Proceedings
PublisherInstitute of Electrical and Electronics Engineers Inc.
ISBN (Electronic)9781479959297
DOIs
StatePublished - 29 Jun 2015
Event12th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2015 - Chicago, United States
Duration: 18 May 201520 May 2015

Publication series

NameISPCE 2015 - IEEE Symposium on Product Compliance Engineering, Proceedings

Conference

Conference12th Annual IEEE Symposium on Product Compliance Engineering, ISPCE 2015
Country/TerritoryUnited States
CityChicago
Period18/05/1520/05/15

Keywords

  • CE Mark
  • certification
  • database system
  • logic-based system
  • mdd
  • medical device
  • technical documentation

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