Establishing Reusable Requirements Derived from Laws and Regulations for Medical Device Development

Dagný Hauksdóttir, Niels Henrik Mortensen, Brian Ritsing, Jens Christian Andersen

Research output: Chapter in Book/Report/Conference proceedingArticle in proceedingsResearchpeer-review

Abstract

For many industries a key activity in product development is to demonstrate legislative compliance by showing, explicitly, that all relevant requirements from regulatory documents have been identified and addressed. The analysis and interpretation of standards and regulations requires considerable skills and consumes significant effort in product development. Therefore initiating reuse from the analysis and elicitation of requirements from standards and regulations may provide promising potential for gaining efficiency in development and also for assuring sufficient quality of the work. In this paper, a method to manage requirements from standards, by establishing a reusable requirements catalogue, is suggested and a metamodel illustrating the information needed for tractability between derived requirements and legal texts, needed to facilitate reuse, is demonstrated. The paper presents a case study, where reusable requirements covering secondary packaging for medical injection devices were established, using a spreadsheet layout to capture and document the information presented in the metamodel.
Original languageEnglish
Title of host publicationProceedings of the 2016 IEEE 24th International Requirements Engineering Conference Workshops
Number of pages9
PublisherIEEE
Publication date2016
Pages220-228
DOIs
Publication statusPublished - 2016
Event2016 IEEE 24th International Requirements Engineering Conference Workshops - Beijing, China
Duration: 12 Sep 201616 Sep 2016

Conference

Conference2016 IEEE 24th International Requirements Engineering Conference Workshops
CountryChina
CityBeijing
Period12/09/201616/09/2016

Keywords

  • Requirements engineering
  • Medical device development
  • Requirements reuse
  • Regulatory compliance

Cite this

Hauksdóttir, D., Mortensen, N. H., Ritsing, B., & Andersen, J. C. (2016). Establishing Reusable Requirements Derived from Laws and Regulations for Medical Device Development. In Proceedings of the 2016 IEEE 24th International Requirements Engineering Conference Workshops (pp. 220-228). IEEE. https://doi.org/10.1109/REW.2016.045