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

INSAFEDARE旨在提供一个工具包，以便在所有利益攸关方作为医疗器械监管的一部分可能遵循的过程中实现具有成本效益和高保证的决策。该工具包包括对保证的科学指导，检索数据集和协助应用程序验证的工具，以及为学科提供可持续支持的公开可用的指导工作组。INSAFEDARE将调查现实世界和合成数据驱动的设备验证的使用、挑战和机遇。该项目将为数据集的质量和安全保证提供指导，作为验证工具，以及使用数据驱动方法进行验证的设备。INSAFEDARE将调查合成数据集的使用情况，并确定如何在正式的、已建立的认证过程之前使用它们来建立保证，从而降低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南，为标准开发工作组奠定基础；并制定能够提高利益相关者技能的培训和教学大纲。最后，该项目将开发一种工具，用于发现、整合和查询多个数据集，并开发一种工具，用于支持设备的可持续、动态和全寿命监测，捕捉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.