The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing your IVD may be considered state of the art. This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.
Who is this webinar for?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission
|March 8, 2023||Watch at a Convenient Time||Recorded|
Takeaways from this session:
How to clearly define what information should (and shouldn't} be presented within the Scientific Validity Report
How the systematic literature review process supports and connects the SVR, CPR, and APR by leveraging published data
How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR