Goal alignment in process improvement

Autor: Lepmets, Marion, McBride, Tom, Ras, Eric

Publikováno v: In The Journal of Systems & Software June 2012 85(6):1440-1452

Agile medical device software development:Introducing agile practices into MDevSPICE

Autor: McCaffery, Fergal, Lepmets, Marion, Trektere, Kitija, Özcan-Top, Özden, Pikkarainen, Minna

Publikováno v: McCaffery, F, Lepmets, M, Trektere, K, Özcan-Top, Ö & Pikkarainen, M 2016, ' Agile medical device software development : Introducing agile practices into MDevSPICE ', International Journal on Advances in Life Sciences, vol. 8, no. 1-2, pp. 133-142 . < http://thinkmind.org/download.php?articleid=lifsci_v8_n12_2016_12 >

Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. In order to devel

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=355e65625b88::00185b3740ad36bb584cb700cd90bf7a
https://cris.vtt.fi/en/publications/0b18a948-4979-4a99-9f95-7905c4f0e312

Piloting MDevSPICE: the medical device software process assessment framework

Autor: Lepmets, Marion, McCaffery, Fergal, Clarke, Paul

Publikováno v: Lepmets, Marion, McCaffery, Fergal and Clarke, Paul (2015) Piloting MDevSPICE: the medical device software process assessment framework. In: The 2015 International Conference on Software and System Process (ICSSP 2015), 24-26 Aug 2015, Tallinn, Estonia. ISBN 978-1-4503-3346-7

Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance doc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od_______119::a6b8bf23b6e9b7ac62329f3659153c9c
http://doras.dcu.ie/21087/

The demands of safety-critical medical device software development

Autor: Clarke, Paul, Lepmets, Marion, McCaffery, Fergal, Finnegan, Anita, Dorling, Alec, Flood, Derek

In the main, software development is a business which is frequently challenged with quality concerns, with the overwhelming majority of software users having experienced some level of difficulty using software at some point in time. One of the primar

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______2656::a1e12b965248def50518674ad69b4f37
http://eprints.dkit.ie/404/

Characteristics of a medical device software development framework

Autor: Clarke, Paul, Lepmets, Marion, Mc Caffery, Fergal, Finnegan, Anita, Dorling, Alec, Eagles, Sherman

peer-reviewed This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and s

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::dc00c096a3e98642dbd88eae6a57998b
http://eprints.dkit.ie/400/