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Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR).
Key Takeaways
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of clinical performance reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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Tags: analytical performance report, clinical performance report, Risk/Benefit Analysis, safety and performance measures, state of the art
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