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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.
Key Takeaways:
Based on the state-of-the-art
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.
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Tags: acceptance criteria, CER, MDR, safety, safety and clinical performance
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
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