Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act - Ketryx Compliance Framework
Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act
60
minutes
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Bringing AI-enabled medical devices to market requires meeting overlapping FDA, EU MDR, and EU AI Act requirements. The AI Act classifies most medical AI as high-risk, introducing expectations for conformity assessment, data governance, transparency, and human oversight alongside MDR’s clinical evaluation and post-market surveillance. In the U.S., the FDA requires full traceability under design control, risk management per ISO 14971, and documented verification and validation of software, algorithms, and data changes across the lifecycle.
The challenge is not understanding the regulations, but operationalizing them. This session explores how to align development and regulatory workflows around shared data, maintain traceability across requirements, risks, and evidence, and reduce manual effort across submissions so teams can move faster while staying audit and submission-ready.
What you'll learn
- How FDA, EU MDR, and the EU AI Act define and enforce requirements, and how AI adds complexity through transparency, human oversight, and data governance
- Strategies to connect shared development artifacts to regulatory evidence, including MDR clinical evaluation and FDA design controls, without duplicating work
- Ways to automatically generate compliant documentation for FDA, MDR, and EU AI Act submissions from shared data to reduce manual effort and accelerate timelines
Who should watch
- Quality and Regulatory teams responsible for multi-region submissions who want to reduce manual effort, improve consistency, and accelerate approvals across FDA, MDR, and EU AI Act requirements
- R&D, Regulatory, and cross-functional leaders involved in bringing products to market across multiple regions and aligning development with compliance requirements
- AI and digital innovation teams exploring how to bring AI-enabled devices to market while meeting evolving expectations for transparency, governance, and validation