IVD Deep Dive: Safety and Performance Objectives and Acceptance Criteria

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

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To watch the free webinar recording, IVD Deep Dive:​ Safety and Performance Objectives and Acceptance Criteria​, fill out the form below.

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​

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