The Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support is a pioneering initiative under the Insafedare program, in collaboration with ETHOS.
This project is designed to advance the use of both real and synthetic data in regulatory decision-making processes, particularly in the medical device industry. By developing robust tools and methodologies, the project aims to ensure the accuracy, reliability, and compliance of data used to validate medical devices before they enter the market. This initiative not only seeks to streamline the regulatory process but also to enhance the safety and effectiveness of medical devices by providing regulatory bodies with high-assurance decision-making tools.
Through its comprehensive approach, the project addresses critical challenges in data quality and regulatory standards, paving the way for innovative and effective regulatory frameworks.
Click on the link to access more information on this project.
