Artificial Intelligence in the context of the IVDR – How to keep the revolution under control
Time: 11:30 am
day: Conference Day One
Details:
The integration of Artificial Intelligence (AI) into In Vitro Diagnostic Medical Devices (IVD) promises transformative advances in patient care and diagnostics and is believed to bear the potential to revolutionize healthcare diagnostics by enhancing accuracy, efficiency, and personalized patient outcomes. However, these innovations must navigate a complex web of regulatory challenges to ensure safety, efficacy, and compliance. Successful implementation of AI will require a collaborative effort by all stakeholders involved in development and conformity assessment.
- Describe the tremendous potential of Artificial Intelligence in the In Vitro Diagnostic Medical Device area
- List challenges related to the regulatory compliance and the ensuring of the safety and effectiveness of IVD(R) AI devices
- Use approaches for demonstrating compliance and considering risks related to IVD AI devices
