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How to Establish the State of the Art Within the Scientific Validity Report
In this practical 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 process.

Key Takeaways:
• The foundational role of the SOA in the SVR
• The required components of the SOA such as the safety and performance objectives
• The importance of a robust systematic literature review (SLR) to support your SOA

Who should attend?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.

Jul 28, 2021 11:00 AM in Pacific Time (US and Canada)

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