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Updated: Jun 13, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
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A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

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在SaMD的整个生命周期中,应对监管挑战

Martina Francesconi1, Miriam Cangi2, Silvia Tamarri2

  • 1Ente di Supporto Tecnico Amministrativo Regionale (ESTAR), Dipartimento Tecnologie Informatiche, Pisa, Italy.

Journal of biomedical informatics
|May 23, 2025
PubMed
概括

这项研究绘制了整个生命周期对软件作为医疗器械 (SaMD) 的欧洲监管要求. 它整合了IEC 62304和ISO 14971等标准,以确保安全有效的SaMD开发.

关键词:
合规性评价 合规性评价 合规性评价生命周期生命周期在MDR中使用MDR.医疗器械 医疗器械 医疗器械规则 规则 规则 规则 规则 规则这就是SaMD的意义.

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