Balancing Expectations to the Health Software Production Process Standard
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Yksityiskohdat
| Alkuperäiskieli | Englanti |
|---|---|
| Otsikko | The 3rd International Virtual Research Conference In Technical Disciplines |
| DOI - pysyväislinkit | |
| Tila | Julkaistu - 2015 |
| OKM-julkaisutyyppi | A4 Artikkeli konferenssijulkaisussa |
| Tapahtuma | International Virtual Research Conference in Technical Disciplines - , Slovakia Kesto: 1 tammikuuta 2000 → … |
Julkaisusarja
| Nimi | RCITD - Proceedings in Research Conference in Technical Disciplines |
|---|---|
| ISSN (painettu) | 2453-6571 |
| ISSN (elektroninen) | 1339-5076 |
Conference
| Conference | International Virtual Research Conference in Technical Disciplines |
|---|---|
| Maa | Slovakia |
| Ajanjakso | 1/01/00 → … |
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.