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In this webinar, we take a deep dive into the best practices to identify appropriate and relevant Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First, using a case study example, we discuss considerations and provide tips to help you select relevant Safety and Performance Objectives for your IVD. Next, we discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Finally we explain how these objectives help establish Acceptance Criteria, a critical input for establishing the SOA in your PER.
Key Takeaways
Based on the state of the art:
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions, or anyone learning more about PER requirements.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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Tags: analytical performance report, clinical performance report, Risk/Benefit Analysis, safety and performance measures, state of the art
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