Regulation Guidance for health technologies

规章制度对保障公众安全至关重要。它们涵盖了作为制造商必须遵守的法律义务。公司需要遵守这些规定才能将产品推向市场。对法规和监管途径的良好理解决定了制造商将创新引入市场的速度和成本。将开发一个新的数字平台，可以支持用户了解和探索其产品的监管途径。最初的重点将放在医疗保健产品上，该团队将开发智能解决方案，以支持和指导创新者遵守相关法规。该平台还将为创新者提供设备特定的监管策略途径，其中包括一般安全和性能要求（GSPR）。它将设备特定信息与标准、测试实验室联系起来，并建议临床路线。这个过程将由用户驱动，项目包括验证用户需求的研究，以及开发的技术。这个平台将是一个概念的证明，从长远来看，它可以扩展到其他地区和行业。它旨在创建一个突破性的创新数字平台，以解决用户在监管过程中遇到的挑战。

Regulations are essential to keep the general public safe. They cover the legal obligations you have to abide to as manufacturer. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. A new digital platform will be developed that can support users to understand and explore the regulatory pathways for their product. The initial focus will be on healthcare products and the team will develop smart solutions to support and guide the innovators through the relevant regulations. The platform will also provide innovators with a device specific regulatory strategy pathway, which includes the general safety and performance requirements (GSPR). It connects device-specific information to standards, test labs and suggest the clinical route. This process will be user driven and the project includes studies to verify the user needs, as well as the technology developed. This platform will be a proof of concept that in the long term can be scaled to other regions, as well as sectors. It aims to create a breakthrough innovative digital platform that tackles the challenges users have with the regulatory process.