In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed.
You will learn:
- The importance of the SOA SLR for providing background and general information
- How to establish acceptance criteria with data
- How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process
Who should attend?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission. Also, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend.
Click here to watch the webinar recording.
IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation
How can scoping help you identify 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, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.
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.
Watch the free webinar recording now.