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).
Discuss the purpose of the CPR and its role as a critical component of the PER
Identify sources of clinical data and analyze those data within the context of the performance endpoints and acceptance criteria presented in the SVR
Demonstrate how to extract, organize, and appraise these data within the CPR
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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