Zobrazeno 1 - 10
of 17
pro vyhledávání: '"Granlund, Tuomas"'
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to medical device
Externí odkaz:
http://arxiv.org/abs/2409.08006
Continuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns needs to be taken into account, it is often considered difficult to apply continuous development approaches
Externí odkaz:
http://arxiv.org/abs/2209.05843
Software of Unknown Provenance, SOUP, refers to a software component that is already developed and widely available from a 3rd party, and that has not been developed, to be integrated into a medical device. From regulatory perspective, SOUP software
Externí odkaz:
http://arxiv.org/abs/2103.09510
The emerging age of connected, digital world means that there are tons of data, distributed to various organizations and their databases. Since this data can be confidential in nature, it cannot always be openly shared in seek of artificial intellige
Externí odkaz:
http://arxiv.org/abs/2103.08937
The medical device products at the European Union market must be safe and effective. To ensure this, medical device manufacturers must comply to the new regulatory requirements brought by the Medical Device Regulation (MDR) and the In Vitro Diagnosti
Externí odkaz:
http://arxiv.org/abs/2103.06809
Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no difference
Externí odkaz:
http://arxiv.org/abs/2103.06815
Publikováno v:
Computer; September 2024, Vol. 57 Issue: 9 p24-34, 11p
Autor:
Ahola, Pasi, Baraian, Andrei, Förger, Klaus, Granlund, Tuomas, Hopia, Jani, Kaikkonen, Risto, Mikkonen, Tommi, Niemirepo, Timo, Pajula, Juha, Partanen, Jari, Pellinen, Timo, Stirbu, Vlad, Torhola, Mika
Publikováno v:
Lähteenmäki, J (ed.), Ahola, P, Baraian, A, Förger, K, Granlund, T, Hopia, J, Kaikkonen, R, Mikkonen, T, Niemirepo, T, Pajula, J, Partanen, J, Pellinen, T, Stirbu, V & Torhola, M 2023, Agile and Holistic Medical Software Development : Final report of AHMED project . VTT Research Report, no. VTT-R-01079-22, VTT Technical Research Centre of Finland .
AHMED is a co-innovation project (https://www.regops.fi/) with six companies (Atostek, Bittium, Mylab, Solita, Taipuva Consulting and Terveystalo) and two research organisations (University of Helsinki and VTT). This report provides summarized result
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=355e65625b88::29a5a875e05cf8040467698485f2a771
https://cris.vtt.fi/en/publications/9cd29f7b-bcc0-4b7a-98b6-5e3e8cc3596e
https://cris.vtt.fi/en/publications/9cd29f7b-bcc0-4b7a-98b6-5e3e8cc3596e
Publikováno v:
Software Quality Journal; Jun2023, Vol. 31 Issue 2, p307-333, 27p
Akademický článek
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