Pregled bibliografske jedinice broj: 587752
Certification and regulatory challenges in medical device software development
Certification and regulatory challenges in medical device software development // Proceedings of the 4th International Workshop on Software Engineering in Health Care (SEHC)
Passau: Conference Publishing Solutions, 2012. str. 40-43 doi:10.1109/SEHC.2012.6227011 (plenarno, nije recenziran, cjeloviti rad (in extenso), stručni)
CROSBI ID: 587752 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Certification and regulatory challenges in medical device software development
Autori
Hrgarek, Nadica
Vrsta, podvrsta i kategorija rada
Radovi u zbornicima skupova, cjeloviti rad (in extenso), stručni
Izvornik
Proceedings of the 4th International Workshop on Software Engineering in Health Care (SEHC)
/ - Passau : Conference Publishing Solutions, 2012, 40-43
ISBN
978-1-4673-1844-0
Skup
4th International Workshop on Software Engineering in Health Care (SEHC)
Mjesto i datum
Zürich, Švicarska, 04.06.2012. - 05.06.2012
Vrsta sudjelovanja
Plenarno
Vrsta recenzije
Nije recenziran
Ključne riječi
medical device software ; mobile medical apps ; regulatory compliance ; usability engineering
Sažetak
The critical nature of safety in medical device software requires a repeatable and compliant software engineering process. This process should take into account the whole development life cycle, risk management, and software verification and validation activities that would commensurate with the device’s complexity and risk. This paper discusses some of the key challenges medical device manufacturers are facing in the development and certification of medical device software. These challenges include: compliance with the EU and US regulatory requirements for medical device software, making software development and maintenance processes more agile in the medical device regulatory environment, integrating usability engineering process/human factors into software development, regulation of networked medical devices and mobile medical applications (apps). The MED-EL case study highlights some of the challenges described in this paper, and the approaches taken to overcome these challenges.
Izvorni jezik
Engleski
Znanstvena područja
Informacijske i komunikacijske znanosti
