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How can scoping help you identify IVDR essentials or critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER. Therefore we have developed strategies to keep you and your team on track and help assess your own level of preparedness. First, using our CE scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates. Then we will explain how each of these fits into the overall process of preparing to write.
Key Takeaways:
This presentation will emphasize the importance of scoping, discuss how to develop a checklist, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process.
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions, and all those interested in learning more about the IVDR essentials needed to write a PER.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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