Streamlining Multi-Region Submissions: Orchestrating MDR, FDA, and EU AI Act Documentation for AI-Enabled Devices

60

minutes

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Bringing AI-enabled medical devices to market means meeting overlapping FDA, EU MDR, and EU AI Act requirements. The AI Act classifies most medical AI as high-risk, requiring conformity assessment, data governance, transparency, and human oversight alongside MDR’s clinical evaluation and post-market surveillance. In the U.S., the FDA expects full traceability under design control, risk management per ISO 14971, and documented verification and validation of software, algorithms, and data changes across the lifecycle.

What you'll learn

• Generate compliant MDR, FDA, and EU AI Act documentation automatically from shared data
• Meet EU AI Act expectations for transparency, human oversight, and data governance in high-risk AI systems
• Link shared development artifacts to MDR clinical evaluation and FDA design control evidence without duplication