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 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.