Regulatory Requirements for Medical Devices Based on Artificial Intelligence : A Didactic Training Concept
Abstract: Artificial intelligence is rapidly transforming healthcare, yet in Europe, there are no standardized regulations for AI-based medical devices under the Medical Device Regulation. This gap necessitates independent compliance verification by medical device manufacturers. This paper addresses the regulatory void by proposing a comprehensive training concept. It equips manufacturers with essential artificial intelligence knowledge and outlines current market introduction challenges. Through pre-tests and training sessions, the concept's efficacy will be assessed and refined. In summary, this work offers insights into AI's transformative potential and regulatory hurdles in healthcare, paving the way for improved standards and practices.
- Standort
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Deutsche Nationalbibliothek Frankfurt am Main
- Umfang
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Online-Ressource
- Sprache
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Englisch
- Erschienen in
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Regulatory Requirements for Medical Devices Based on Artificial Intelligence ; volume:10 ; number:4 ; year:2024 ; pages:457-460 ; extent:4
Current directions in biomedical engineering ; 10, Heft 4 (2024), 457-460 (gesamt 4)
- Urheber
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Nguyen, My Duyen
Sohrabi, Keywan
Gross, Volker
Scholtes, Michael
Seifert, Oskar
- DOI
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10.1515/cdbme-2024-2112
- URN
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urn:nbn:de:101:1-2412181733263.821100126508
- Rechteinformation
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Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Letzte Aktualisierung
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15.08.2025, 07:37 MESZ
Datenpartner
Deutsche Nationalbibliothek. Bei Fragen zum Objekt wenden Sie sich bitte an den Datenpartner.
Beteiligte
- Nguyen, My Duyen
- Sohrabi, Keywan
- Gross, Volker
- Scholtes, Michael
- Seifert, Oskar
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