Dies ist eine Übersichtsseite mit Metadaten zu dieser wissenschaftlichen Arbeit. Der vollständige Artikel ist beim Verlag verfügbar.
Impact of GAMP 5 Guidelines on Validation of AI-Powered Medical Device Software
1
Zitationen
3
Autoren
2024
Jahr
Abstract
The integration of artificial intelligence (AI) into medical device software has revolutionized healthcare by enhancing diagnostic accuracy, treatment efficiency, and patient outcomes. However, ensuring the reliability, safety, and regulatory compliance of AI-powered medical devices presents significant challenges. The Good Automated Manufacturing Practice (GAMP 5) guidelines provide a structured framework for validating automated systems, including AI-driven medical software. This study explores the impact of GAMP 5 guidelines on the validation process of AI-powered medical devices, addressing key aspects such as risk management, data integrity, and lifecycle management. Through a detailed analysis of regulatory requirements and case studies, this research highlights best practices for aligning AI-driven medical device validation with GAMP 5 principles. The findings underscore the importance of robust validation methodologies to ensure compliance, improve software performance, and enhance patient safety.
Ähnliche Arbeiten
Explainable Artificial Intelligence (XAI): Concepts, taxonomies, opportunities and challenges toward responsible AI
2019 · 8.339 Zit.
Stop explaining black box machine learning models for high stakes decisions and use interpretable models instead
2019 · 8.211 Zit.
High-performance medicine: the convergence of human and artificial intelligence
2018 · 7.614 Zit.
Proceedings of the 19th International Joint Conference on Artificial Intelligence
2005 · 5.776 Zit.
Peeking Inside the Black-Box: A Survey on Explainable Artificial Intelligence (XAI)
2018 · 5.478 Zit.