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).
Key Takeaways: • Review the essential steps for conducting a robust, methodologically-sound systematic literature review
• Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.
Who should watch this webinar? Those Regulatory, Quality and Clinical leaders and regulatory writers 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.
[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions
In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.
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