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How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation […] |
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This session's topic: Safety and Performance Measures and Acceptance Criteria for MDR Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically […] |
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IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we'll present strategies to keep you and your team on track and help assess your own […] |
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 Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define safety and performance objectives? What are the biggest pitfalls or "Achille's heels" to watch out for in identifying safety and performance measures? In this webinar, we'll take a deep dive into the best practices to identify relevant […] |
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