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 process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines.
- 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 watch the recording?
Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are develop, write, review, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well.
Click here to watch the recording of this webinar.
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.