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15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference

We are thrilled to invite you this year in person to Washington, D.C. for the 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference on May 11-12, 2023. This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. Stay tuned for more updates on the agenda and speakers. Registration will open soon!

Conference Topics will include:
• Dialogue with the New FDA/CDRH Biostatistics Division Director
• External Evidence in the Evaluation of Medical Devices
• Methods for AI/Machine Learning as a Medical Device
• The Analytical Bridging Study or Migration Study and its Study Design, Acceptance Criteria, and Statistical Analysis
• Challenges in Validating Device Output
• Statistical Issues/Challenges in the Evaluation of Digital Pathology Devices
• Latest Standards Revisions and Guidance Documents in Analytical Studies, and the Applicability to the Newest Technology, such as Next-Generation Sequencing Test
• Complex Innovative Design in Medical Devices.
• Challenges with the Pandemic – What Now?
• Subgroup Analysis

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