电子书

提高医疗器械监管信息的透明度

一位女人围坐在同事中间,在监管小组会议上发言

监管信息管理是一项复杂的挑战,许多医疗器械制造商都在努力应对不同的系统和手动跟踪。为了适应不断变化的法规,培养以质量为基础的文化至关重要。优先考虑合规性不仅可以提高产品质量,还可以使新的和高风险的医疗技术受益。我们的闭环质量与合规工具可实现可追溯、可控的监管信息管理,从而在整个产品生命周期中加强与卫生机构的互动。

通过监管信息管理系统集中监管数据

使用我们的闭环质量与合规工具,将所有监管数据集中在一个简化的监管信息管理系统(RIMS)中,提高对于内部和外部利益相关者的透明度。这种集成式数据管理系统确保了从文档到数据的所有必要信息的可用性。轻松确定与监管机构共享的内容并监控这些交互,使质量和监管团队能够有效地创建产品提交。

闭环质量与合规信息工具的优势:

  • 提高合规性
  • 促进协同
  • 强制执行正确的数据
  • 加快产品发布

阅读电子书,了解更多信息。

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