Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for assessing critical components of your PER for possible misalignment with key IVDR requirements. This presentation seeks to help you assess your PER processes and document for possible gaps prior to submission.
Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
|February 23rd, 2022
|11am PST | 2pm EST