[FREE WEBINAR] How to Assess Your CER for MDR Readiness, Part 2: Clinical Data Sources, Equivalence, and Risk/Benefit Analysis

Get a copy of the slides from this webinar or click to watch the recording.

In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities. In this series, we will examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER. 

In the first webinar of this series, we discussed the State of the Art, Safety & Performance Criteria, Equivalence, and Systematic Literature Review.
Click here to get the slides and watch the recording for part 1.

Key Takeaways:
• Understand the key components of a clinical evaluation report (1-min review of last webinar, clinical evidence, SLR, risk benefit, conclusion – have you ensured that your conclusion reflects conclusions from other sections/data?) 
• Determine how to evaluate your CER for key requirements of the MDR 

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 Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Sign up for future webinars here.

If you enjoyed this webinar and would like a free consultation, please contact us here.

About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

Get in Touch

Recent Posts