A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
In this practical presentation, we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, this webinar illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
How to Assess Your CER for MDR Readiness, Part 2
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
State of the Art Literature Review for EU MDR Compliance: How To Get It Right
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.