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Software as Medical Devices: requirements and regulatory landscape in the United States
2
Zitationen
4
Autoren
2025
Jahr
Abstract
The Total Product Lifecycle (TPLC) framework is essential for managing evolving risks and performance of AI/ML-based SaMD. These technologies are redefining regulatory assumptions, requiring systems that ensure transparency, mitigate bias, sustain trust, and promote equitable, safe innovation.
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