Towards Medical Device Behavioural Validation Using Petri Nets

Paulo E S Barbosa, Misael Morais, Katia Galdino, Melquisedec Andrade, Luís Filipe dos Santos Gomes, Filipe Moutinho, Jorge C A Figueiredo

Research output: Chapter in Book/Report/Conference proceedingConference contribution

6 Citations (Scopus)

Abstract

Medical devices development and validation are difficult activities due to the critical nature of these products, involving risks to the human lives. Moreover, regulatory agencies are increasing the control over companies because of the still huge number of harms caused for several reasons, having software failures as one of the main causes. Thus it is clear that more formal and sophisticated software development techniques should be investigated. In this paper, we show how Petri nets can play the role of a generic framework for architectural decisions for control systems, allowing besides verification/simulation, an important bridge in the requested traceability by regulatory bodies. We claim that it is possible to satisfy traceability from architectural elements to code, test cases, functional and safety requirements and so on. In order to make clear our point, we conducted a case study from a generic infusion pump specification.
Original languageEnglish
Title of host publication2013 IEEE 26th International Symposium on Computer-Based Medical Systems (CBMS)
Place of PublicationNew York
PublisherInstitute of Electrical and Electronics Engineers Inc.
Pages4-10
ISBN (Electronic)978-1-4799-1053-3
ISBN (Print)978-1-4799-1052-6
DOIs
Publication statusPublished - 2013
Event26th IEEE International Symposium on Computer-Based Medical Systems (CBMS 2013) - Porto, Portugal
Duration: 20 Jun 201322 Jun 2013
Conference number: 26th

Conference

Conference26th IEEE International Symposium on Computer-Based Medical Systems (CBMS 2013)
Abbreviated titleCBMS 2013
CountryPortugal
CityPorto
Period20/06/1322/06/13

Keywords

  • Architectural decision
  • Architectural element
  • Generic frameworks
  • Regulatory agencies
  • Regulatory bodies
  • Safety requirements
  • Software development techniques
  • Software failure

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