TUTCRIS - Tampereen teknillinen yliopisto

TUTCRIS

Balancing Expectations to the Health Software Production Process Standard

Tutkimustuotosvertaisarvioitu

Yksityiskohdat

AlkuperäiskieliEnglanti
OtsikkoThe 3rd International Virtual Research Conference In Technical Disciplines
DOI - pysyväislinkit
TilaJulkaistu - 2015
OKM-julkaisutyyppiA4 Artikkeli konferenssijulkaisussa
TapahtumaInternational Virtual Research Conference in Technical Disciplines - , Slovakia
Kesto: 1 tammikuuta 2000 → …

Julkaisusarja

NimiRCITD - Proceedings in Research Conference in Technical Disciplines
ISSN (painettu)2453-6571
ISSN (elektroninen)1339-5076

Conference

ConferenceInternational Virtual Research Conference in Technical Disciplines
MaaSlovakia
Ajanjakso1/01/00 → …

Tiivistelmä

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.

Julkaisufoorumi-taso