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How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience developing MDR compliant CER templates and recent authorship of MDR-ready CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

Key Takeaways:
• Identify key MDR requirements that are applicable to critical components of a CER
• Apply review strategies to help evaluate your CER for alignment with MDR requirements
• Why organization, structure and clear language really matter in your CER

Who should attend?
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.

Looking for more guidance before the deadline? Register for part 2 of this webinar, Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions here: https://criterionedge.zoom.us/webinar/register/9516183630957/WN_8A7EaVeKRh2H8rypjK5alg

Register for Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing. Identify those hidden gaps in resources, information and the steps to take to mitigate them here: https://criterionedge.zoom.us/webinar/register/9016183629969/WN_YaXLFRMDTZiUT9bIzhwSTg

May 5, 2021 11:00 AM in Pacific Time (US and Canada)

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Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: Jessica Sinha.