Sökning: (id:"swepub:oai:DiVA.org:hj-59486") >
Market Launch and R...
Market Launch and Regulative Assessment of ICT-Based Medical Devices : Case Study and Problem Definition
-
- Piwowarczyk vel Dabrowski, Maciej (författare)
- Institute of Computer Science, University of Rostock, Rostock, Germany; Fraunhofer FOKUS, Berlin, Germany
-
- Sandkuhl, Kurt, 1963- (författare)
- Jönköping University,JTH, Avdelningen för datateknik och informatik,Institute of Computer Science, University of Rostock, Rostock, Germany
-
(creator_code:org_t)
- 2022-04-06
- 2022
- Engelska.
-
Ingår i: Business Information Systems Workshops. - Cham : Springer. - 9783031042157 - 9783031042164 ; , s. 304-315
- Relaterad länk:
-
https://urn.kb.se/re...
-
visa fler...
-
https://doi.org/10.1...
-
visa färre...
Abstract
Ämnesord
Stäng
- The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no established standards, best practices or support tools how to launch medical devices on the market. The paper is part of a project aiming for methodical support for medical device launch and assessment, and is dedicated to investigating problem relevance. To understand the processes and requirements three case studies were analysed and the necessary processes and requirements were matched towards enterprise architectures (EA). Based on this finding, we argue that EA could be a suitable way to visualize and recommend required processes and structures for medical device management. The main contributions of our work are (a) a literature analysis of EA use in health care and especially for telemedicine, (b) results from use case analysis investigating the business perspective from inside three health tech companies and (c) the analysis of problems of telemedicine integration into EA.
Ämnesord
- TEKNIK OCH TEKNOLOGIER -- Maskinteknik -- Produktionsteknik, arbetsvetenskap och ergonomi (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Mechanical Engineering -- Production Engineering, Human Work Science and Ergonomics (hsv//eng)
- NATURVETENSKAP -- Data- och informationsvetenskap -- Systemvetenskap, informationssystem och informatik (hsv//swe)
- NATURAL SCIENCES -- Computer and Information Sciences -- Information Systems (hsv//eng)
Nyckelord
- Assessment process
- Enterprise architecture
- Market launch
- Medical device
- Commerce
- Systems engineering
- Best practices
- Case-studies
- Engineering management
- Medical Devices
- Problem definition
- Product management
- Requirement engineering
- Telemedicine
Publikations- och innehållstyp
- ref (ämneskategori)
- kon (ämneskategori)
Hitta via bibliotek
Till lärosätets databas