Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and define acceptance criteria parameters to support the benefit-risk analysis.
|March 2nd, 2022||11am PST | 2pm EST||Virtual|
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