Key Takeaways:
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.
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
