Regulation Guidance for health technologies

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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.