This webinar is presented from the point of view of seasoned MDR-compliant CER medical writers. Criterion Edge discusses strategies for the verification of device safety and performance in the clinical evaluation. Next, we teach you how to identify meaningful safety and performance measures for the clinical evaluation and define parameters to determine the acceptability of benefit-risk.
Based on the state-of-the-art
Identify meaningful safety and performance endpoints (measures/objectives)
Demonstrate that safety and performance objectives are appropriate and clinically relevant
Specify acceptance criteria that are used to determine the acceptability of benefit-risk
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and regulatory writers who develop, write, review or approve Clinical Evaluation Reports for EU MDR submission. Additionally, anyone interested in learning more about MDR requirements for CERs is encouraged to watch as well. Finally, we encourage viewers from the IVD industry as well, as the content is relevant to IVDR requirements, which align closely with MDR.
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