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, presents focused strategies on building an IVDR-aligned SOA section within the SVR. She also talks about the critical role of the SVR as it relates to the overall performance evaluation process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays, and how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines.


Who should watch this session?


Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.

February 2nd, 2022 11am PST | 2pm EST Virtual

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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
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