Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze […]
This session's topic: Safety and Performance Objectives and Acceptance Criteria for IVDR Do you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are the best methods and practices for identifying acceptance criteria? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant? During this […]
This session's topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance Are you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session, our President Laurie Mitchell answers questions regarding […]
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