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相关概念视频

Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Bacterial Signaling01:30

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Bacterial signaling can occur within bacteria (intracellular) or between bacteria (intercellular). At times, a group of bacteria behaves like a community. To achieve this, they engage in quorum sensing, the perception of higher cell density that causes changes in gene expression. Quorum sensing involves both extracellular and intracellular signaling. The signaling cascade starts with a molecule called an autoinducer (AI). Individual bacteria produce AIs that move out of the bacterial cell...
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相关实验视频

Updated: Jul 12, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
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医疗器械软件:从要求到认证

Noemi Giordano1, Samanta Rosati1, Gabriella Balestra1

  • 1Department of Electronics and Telecommunication, Politecnico di Torino, Italy.

Studies in health technology and informatics
|October 23, 2023
PubMed
概括

开发符合标准的医疗器械软件 (MDS) 需要监管管道. 这个过程整合了要求,风险评估和有效性分析,从概念到实施,实现欧盟认证.

科学领域:

  • 医疗信息学 医疗信息学
  • 监管科学 监管科学
  • 软件工程 软件工程 软件工程

背景情况:

  • 医疗保健软件越来越普遍,但往往忽视其作为医疗器械的地位.
  • 对于软件制造商来说,遵守欧盟医疗器械法规2017/745对于软件制造商来说至关重要.
  • 不遵守法规可能会阻碍市场准入和患者安全.

研究的目的:

  • 为开发可认证的医疗器械软件 (MDS) 提出一个全面的管道.
  • 确保MDS的开发符合欧盟医疗器械法规2017/745的要求.
  • 概述整个MDS生命周期中监管合规性的关键阶段.

主要方法:

  • 开发一个医疗设备软件 (MDS) 的结构化管道.
  • 整合要求提取,风险评估和有效性分析.
  • 与MDS设计和实施并行准备技术文件.

主要成果:

  • 拟议的管道有助于创建符合监管标准的MDS.
  • 根据欧盟MDR 2017/745.5确定成功认证的关键阶段.
  • 强调开发和技术文档的并行处理.
关键词:
通过MDS认证,可以获得MDS认证.医疗器械软件 医疗器械软件

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相关实验视频

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结论:

  • 对于MDS的认证过程始于概念化,并通过设计和实施继续进行.
  • 采用结构化管道可确保遵守欧盟医疗器械法规2017/745.
  • 积极整合监管要求简化了医疗保健软件进入市场的道路.