Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to define safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio related to the CER. Our experts discuss how to develop MDR-aligned safety and performance objectives, how clinical outcomes are leveraged, and tie it all together in the Risk-Benefit section of the CER.
How to effectively identify, present and analyze CER parameters
Understand how clinical outcomes differentiate from S&P objectives
Learn how these key foundational concepts “tell the story” of the CER
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.
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