创建一个合格的医疗器械开发工具自动注射器的框架
1Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Frontiers in medical technology
|December 22, 2023
概括
本研究提出了一个医疗设备开发工具 (MDDT) 框架用于自动注射器,使用ISO 11608-1:2022主要功能. 该框架旨在标准化自动注射器的开发,并简化FDA对组合产品的批准.
科学领域:
- 生物医学工程 生物医学工程
- 药物输送系统 药物输送系统
- 监管科学 监管科学
背景情况:
- 自动注射器对于自给药非常重要,但缺乏专门的医疗设备开发工具 (MDDT).
- 这种缺失可能导致组合产品中自动注射器质量和监管合规性不一致.
- 现有的FDA资源和ISO标准为开发专门工具提供了基础.
研究的目的:
- 专门为自动注射器开发一个全面的MDDT框架.
- 为了利用ISO 11608-1:2022中定义的主要功能来开发自动注射器.
- 解决用于组合产品中自动注射器标准化开发工具的缺口.
主要方法:
- 对现有的FDA批准的MDDT进行分析.
- 审查FDA的设计控制法规和自动注射器指南.
- 从ISO 11608-1:2022中应用主要功能 (例如,保持力,剂量精度).
主要成果:
- 确定自动注射器的关键主要功能:保持力,盖子移除力,激活力,延长针的长度,注射时间,剂量精度和针锁定.
- 关于自动注射器MDDT开发的结构化框架的建议.
- 通过将主要功能与FDA的MDDT方法集成来弥合差距.
结论:
- 介绍了一种针对自动注射器开发的新型MDDT框架.
- 该框架提高了自动注射器开发和监管审查的可预测性和有效性.
- 这种方法旨在加快FDA对组合产品中使用的自喷器的批准.
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