INSAFEDARE: INNOVATIVE APPLICATIONS OF ASSESSMENT AND ASSURANCE OF DATA AND SYNTHETIC DATA FOR REGULATORY DECISION SUPPORT

INSAFEDARE的目标是提供一个工具包，以便在所有利益相关者可能作为医疗器械监管的一部分遵循的过程中，能够进行具有成本效益和高度保证的决策。该工具包包括关于保证的科学指导、检索数据集和协助应用程序验证的工具，以及公开提供的可持续支持该学科的指导工作组。INSAFEDARE将调查真实世界和合成数据驱动的设备验证的使用、挑战和机会。该项目将就作为验证工具的数据集以及使用数据驱动方法进行验证的设备的质量和安全保证提供指导。INSAFEDARE将调查合成数据集的使用情况，并将确定如何使用它们在正式的既定认证过程之前建立保证，从而减少开发人员的风险和监管机构的浪费。此外，该项目将公布调查结果作为公共指导，为建立一个标准的发展工作组奠定基础；并制定可提高利益攸关方技能的培训和教学大纲。最后，该项目将开发一个用于发现、集成和查询多个数据集的工具，以及一个用于支持对设备进行可持续、动态和终身监控的工具，以捕获新发布的数据集提供的新证据的影响。

INSAFEDARE aims to provide a toolkit to enable cost-effective and high assurance decision-making in the context of the processes that all stakeholders may follow as part of regulation of medical devices. The toolkit consists of scientific guidance on assurance, tools to retrieve datasets and assist application validation and a publicly available guidance work-group for sustainable support of the discipline. INSAFEDARE will investigate use, challenges, and opportunities real world and synthetic data-driven validation of devices. The project will provide guidance on quality and safety assurance of datasets as a tool for validation, and devices that have validated using data driven approaches. INSAFEDARE will investigate use of synthetic datasets and will identify how they can be used to establish assurance before the formal, established certification process, reducing the risk for developers and waste for regulatory bodies. Furthermore, the project will publish the findings as a public guidance, laying the ground for a standard development working group; and develop training and syllabus that can enhance the skills of stakeholders. Finally, the project will develop a tool for the discovery, integration, and query of multiple datasets, and a tool for supporting the sustainable, dynamic, and through-life surveillance of devices, capturing the impact of new evidence offered by newly published datasets.