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Balancing Expectations to the Health Software Production Process Standard

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


Original languageEnglish
Title of host publicationThe 3rd International Virtual Research Conference In Technical Disciplines
Publication statusPublished - 2015
Publication typeA4 Article in a conference publication
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


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


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.

Publication forum classification

Field of science, Statistics Finland