[FREE WEBINAR] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

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This webinar is presented from the point of view of seasoned MDR-compliant CER medical writers. Criterion Edge discusses strategies for the verification of device safety and performance in the clinical evaluation. Next, we teach you how to identify meaningful safety and performance measures for the clinical evaluation and define parameters to determine the acceptability of benefit-risk.

Key Takeaways:

Based on the state-of-the-art

  • Identify meaningful safety and performance endpoints (measures/objectives) 
  • Demonstrate that safety and 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 regulatory writers who develop, write, review or approve Clinical Evaluation Reports for EU MDR submission. Additionally, anyone interested in learning more about MDR requirements for CERs is encouraged to watch as well. Finally, we encourage viewers from the IVD industry as well, as the content is relevant to IVDR requirements, which align closely with MDR. 

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

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