Syntho joins INSAFEDARE to transform medical device regulation with synthetic data

Syntho was proud to be selected as one of only 10 organizations to participate in the INSAFEDARE (Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support) project, funded by the European Commission. This initiative aims to develop a toolkit that revolutionizes medical device regulation. The other organizations participating in this project include:

• The University of Warwick
• The European Federation of Medical Informatics
• The Open Group
• Italian Institute for Privacy
• The French Alternative Energies and Atomic Energy Commission
• HTCert
• ETHOS
• Leiden University Medical Centre

Accelerating the approval process for medical devices with Synthetic Data

Traditionally, medical device regulation relies heavily on physical testing and clinical trials. While crucial, these methods can be time-consuming, expensive, and limited in scope. INSAFEDARE aims to revolutionize this process by exploring the potential of synthetic data.

Synthetic data offers a safe and efficient way to simulate various scenarios and test a device’s performance under diverse conditions. This allows for a more comprehensive evaluation before reaching the formal certification stage.

Syntho, a leader in synthetic data generation, brings its expertise to investigate how synthetic data can be used to establish assurance for medical devices before formal certification. This approach holds immense promise for reducing risks and accelerating the approval process for developers and regulatory bodies alike.

A Smarter, Faster, and More Effective Future

By incorporating synthetic data into the regulatory process, INSAFEDARE intends to have a future where medical device regulation is:

• Smarter: Utilizing synthetic data allows for a more nuanced understanding of a device’s capabilities and limitations.
• Faster: Synthetic data testing can significantly reduce the time needed for pre-certification, accelerating the path to market for innovative devices.
• More Effective: By simulating a wider range of scenarios, synthetic data can contribute to a more robust and efficient regulatory process.

This collaboration between leading organizations and the INSAFEDARE project places us at the forefront of this exciting transformation.