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 number: 24
    https://ieeexplore.ieee.org/xpl/conhome/7801359/proceeding

    Conference

    Conference2016 IEEE 24th International Requirements Engineering Conference Workshops
    Number24
    Country/TerritoryChina
    CityBeijing
    Period12/09/201616/09/2016
    Internet address

    Keywords

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

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