You have planned a time to complete your Clinical Evaluation Reports to meet the upcoming MDR deadline, but when your team sits down to write, will they have everything they need to complete the job?
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more up-front planning than the reports have in the past, and the last thing you want to do is torpedo your writing project timeline by not having everything your team needs when that project begins.
Based on our experiences with clients both large and small, our President, Laurie Mitchell, will share with you some of the biggest issues we have discovered when starting an MDR CER project. And Laurie will also reveal some of the most successful strategies in addressing these issues, up-front and early.
[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions
In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.
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