In Silico Clinical-Trials: Advancing Validation for Regulatory Approval

The assesment of the safety and efficacy of medical devices can be time-consuming, expensive, and raise ethical concerns. Additionally, the high costs of innovation and lengthy development times may result in increased prices and unequal access for certain patient groups. In silico clinical trials (...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής

Κύριοι συγγραφείς:	Leuchter Matthias, Supp Laura, Oldenburg Jan, Stiehm Michael, Schmitz Klaus-Peter, Borowski Finja
Μορφή:	Artigo
Γλώσσα:	Inglês
Έκδοση:	De Gruyter 2025-09-01
Σειρά:	Current Directions in Biomedical Engineering
Θέματα:	isct credibility fda medical device regulation regulatory affairs
Διαθέσιμο Online:	https://doi.org/10.1515/cdbme-2025-0202
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