Nav.AI: a cognitive assisted digital regulatory navigation platform for health product innovators

专为卫生部门设计的产品涵盖了非常广泛的形式和功能。为在该部门使用而设计的产品可能具有医疗功能，从而使该产品成为医疗产品或医疗器械产品，或者它们可能不属于产品分类要求。管理该行业的法规、标准和指导意见很复杂，开发商发现很难驾驭。产品开发人员必须通过监管迷宫，满足监管要求，才能销售产品。NAV.AI旨在开发一个认知辅助平台，以指导用户通过错综复杂的健康相关产品法规，并在回答以下问题的基础上：*产品旨在实现什么*产品如何实现其目标*开发商希望对产品提出的声明*关于医疗器械、药物化合物和疾病分类的公开数据为产品确定最合适的分类，即它是医疗器械(医疗器械、IVD或主动植入式医疗器械)还是其他形式的受监管产品？该平台还将确定该产品必须遵守的任何其他法规。一旦平台确定了产品的类型，它将确定可用于获得销售该产品所需的UKCA和/或欧盟CE标志的选项。该项目具有创新性，因为现有的用于保健品行业的合规软件旨在帮助用户保持合规，而不是确定产品应遵守的法规。该平台旨在为产品开发人员提供一个路线图，指导他们如何证明其产品符合相关法规、标准以及可帮助他们实现这一目标的可用资源。由于NAV.AI的目的是原则上的证明，因此将考虑较小的法规子集。该平台将使用产品详细信息进行测试，并根据其正确识别适用的法规、标准等的能力进行判断，这些法规和标准是产品必须遵守的，以及满足这些要求的可用支持。

Products designed for use in the health sector cover a very wide range of form and function. Products designed for use in this sector may have a medical function which makes the product either a medicinal product or a medical device product or they may fall outside the product classification requirements. The regulations, standards and guidance which govern the sector are complex and present a maze which developers find difficult to navigate. A product developer must navigate this regulatory maze and meet the regulatory requirements before a product can be sold. NAV.AI aims to develop a cognitively assisted platform to guide a user through the maze of regulations for health related products and on the basis answers to questions about* What the product is designed to achieve* How the product achieves its goal* The claims the developer wishes to make for the product* Publicly available data regarding medical device, medicinal compound and disease classificationidentify the most appropriate classification for the product i.e. is it a medical device (Medical Device, IVD or active implantable medical device) or some other form of regulated product? The platform will also identify any other regulations which the product must comply with. Once the platform has determined the type of product it will then determine the options available for obtaining a UKCA and/or a EU CE mark required to sell the product. The project is innovative since the compliance software available that is designed for use in the health products industry, are designed to help the user maintain regulatory compliance and not identify the regulations which a product should comply with. This platform aims to provide product developers with a road map for how to demonstrate the compliance of their product with the relevant regulations, standards and the resources available to help them achieve it. Since the aim of NAV.AI is a proof of principle, a smaller subset of regulations will be considered. The platform will be tested using product details and judged against its ability to correctly identify the applicable regulations standards etc, which the product must comply with and the support available to meet those requirements.