Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Hidden Traps That Can Derail Your CER: Answer These Critical Questions Before You Start Writing
Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
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.