IVD Deep Dive Part 1: Safety and Performance Objectives and Acceptance Criteria

#IVDR #ClinicalPerformance #PerformanceMeasures #AcceptanceCriteria #BenefitRisk

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.

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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 this webinar?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.

Speaker
Dr. Sarah Chavez

Principal Medical Writer with Criterion Edge with a BS in Biochemistry and a PhD in Molecular and Cellular Biology. Sarah has 25 years of laboratory bench experience and has taught at the University level for the past 15 years.​ She has extensive scientific writing experience in an academic environment, as well as for several large textbook publishers. Sarah’s strong background in basic research and her extensive experience with regulatory writing will allow her to assist companies with IVDR readiness as part of the Criterion Edge team.