Click here to watch the recording of this webinar.
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.
Key Takeaways
- 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.
Who are the Panelists?
President Laurie Mitchell
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
