Key Takeaways
Based on the state of the art:
- Identify meaningful performance endpoints (measures/objectives)
- Demonstrate that 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 teams who develop, write, review, or approve performance evaluation reports for IVDR submissions, or anyone learning more about PER requirements.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
