Navigating Global Regulatory Expectations for Software & AI Enabled Devices

• Understand how FDA, EU MDR, and the EU AI Act expectations intersect
• Learn where global evidence can be reused versus duplicated
• Explore traceability and UDI expectations for software
• Leave with a more efficient global submission strategy

Speakers:

Abhineet Johri

Regulatory Affairs Quality Assuarance Professional

Siemens Healthcare Diagnostics