Regulation Guidance for health technologies

卫生技术监管指南

• 批准号: 10021938
• 金额: $ 109.38万
• 依托单位: REG METRICS LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10021938
• 关键词: Regulation; Guidance; health; technologies

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.

规章制度对保障公众安全至关重要。它们涵盖了你作为制造商必须遵守的法律的义务。公司需要遵守法规，以便将其产品推向市场。对法规和监管途径的良好理解决定了制造商能够以多快的速度和多高的成本将创新引入市场。将开发一个新的数字平台，支持用户了解和探索其产品的监管途径。最初的重点将是医疗保健产品，该团队将开发智能解决方案，以支持和指导创新者通过相关法规。该平台还将为创新者提供特定于器械的监管策略途径，其中包括一般安全性和性能要求（GSPR）。它将设备特定信息与标准、测试实验室联系起来，并建议临床路径。这一过程将由用户驱动，项目包括研究以核实用户需求以及开发的技术。这个平台将是一个概念验证，从长远来看，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，解决用户在监管过程中面临的挑战。