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Balancing Expectations to the Health Software Production Process Standard

Tutkimustuotosvertaisarvioitu

Standard

Balancing Expectations to the Health Software Production Process Standard. / Värri, Alpo.

The 3rd International Virtual Research Conference In Technical Disciplines. 2015. (RCITD - Proceedings in Research Conference in Technical Disciplines).

Tutkimustuotosvertaisarvioitu

Harvard

Värri, A 2015, Balancing Expectations to the Health Software Production Process Standard. julkaisussa The 3rd International Virtual Research Conference In Technical Disciplines. RCITD - Proceedings in Research Conference in Technical Disciplines, Slovakia, 1/01/00. https://doi.org/10.18638/rcitd.2015.3.1.71

APA

Värri, A. (2015). Balancing Expectations to the Health Software Production Process Standard. teoksessa The 3rd International Virtual Research Conference In Technical Disciplines (RCITD - Proceedings in Research Conference in Technical Disciplines). https://doi.org/10.18638/rcitd.2015.3.1.71

Vancouver

Värri A. Balancing Expectations to the Health Software Production Process Standard. julkaisussa The 3rd International Virtual Research Conference In Technical Disciplines. 2015. (RCITD - Proceedings in Research Conference in Technical Disciplines). https://doi.org/10.18638/rcitd.2015.3.1.71

Author

Värri, Alpo. / Balancing Expectations to the Health Software Production Process Standard. The 3rd International Virtual Research Conference In Technical Disciplines. 2015. (RCITD - Proceedings in Research Conference in Technical Disciplines).

Bibtex - Lataa

@inproceedings{9819edb69e2a4909a03c3ef5f25da6ef,
title = "Balancing Expectations to the Health Software Production Process Standard",
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.",
author = "Alpo V{\"a}rri",
year = "2015",
doi = "10.18638/rcitd.2015.3.1.71",
language = "English",
isbn = "978-80-554-1125-5",
series = "RCITD - Proceedings in Research Conference in Technical Disciplines",
booktitle = "The 3rd International Virtual Research Conference In Technical Disciplines",

}

RIS (suitable for import to EndNote) - Lataa

TY - GEN

T1 - Balancing Expectations to the Health Software Production Process Standard

AU - Värri, Alpo

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

U2 - 10.18638/rcitd.2015.3.1.71

DO - 10.18638/rcitd.2015.3.1.71

M3 - Conference contribution

SN - 978-80-554-1125-5

T3 - RCITD - Proceedings in Research Conference in Technical Disciplines

BT - The 3rd International Virtual Research Conference In Technical Disciplines

ER -