Balancing Expectations to the Health Software Production Process Standard

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

    Abstract

    This paper presents the stakeholder expectations to the new version of the ISO/IEC health software life cycle standard 62304. This software production standard is central to the medical device industry but the new version is expected to cover even more scope including also other health software than just regulated medical device software. This paper discusses how to balance the expectations of the law makers, regulatory bodies, software producers and users etc. Compared to the present version the new version should take more into account the special characteristics of developing low risk mobile health application software and cybersecurity while maintaining the endorsement of the regulatory bodies.
    Original languageEnglish
    Title of host publicationThe 3rd International Virtual Research Conference In Technical Disciplines
    DOIs
    Publication statusPublished - 2015
    Publication typeA4 Article in conference proceedings
    EventInternational Virtual Research Conference in Technical Disciplines - , Slovakia
    Duration: 1 Jan 2000 → …

    Publication series

    NameRCITD - Proceedings in Research Conference in Technical Disciplines
    ISSN (Print)2453-6571
    ISSN (Electronic)1339-5076

    Conference

    ConferenceInternational Virtual Research Conference in Technical Disciplines
    Country/TerritorySlovakia
    Period1/01/00 → …

    Publication forum classification

    • Publication forum level 0

    Fingerprint

    Dive into the research topics of 'Balancing Expectations to the Health Software Production Process Standard'. Together they form a unique fingerprint.

    Cite this