IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for assessing critical components of your PER for possible misalignment with key IVDR requirements. This presentation seeks to help you assess your PER processes and document for possible gaps prior to submission.


Who should watch this session?


Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.

February 23rd, 2022 11am PST | 2pm EST Virtual

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Key Takeaways:

  • Strategically review a PER for clearly stated purpose statements, clear documentation of methodology and logical flow and organization
  • Assess your PER for IVDR alignment by reviewing for common gaps found in the following:
    • Clinical Data Sources
    • State of the Art
    • Performance Objectives
    • Risk Benefit Analysis
  • Why organization and a solid template and structure really matter in a PER
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