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[Ask the Expert] Safety and Performance

Virtual Q&A

This session's topic: Safety and Performance Measures and Acceptance Criteria Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do […]

[Ask the Expert] The Importance of Clinical Data

Virtual Q&A

The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER Do you have questions about how to generate, collect, analyze, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you […]

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