With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER). By performing a gap analysis and assessing the readiness and availability of critical resources, documents and expertise, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful, IVDR-compliant PER.
Who's is this Webinar For?
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.
|June 28, 2023||Watch at a Convenient Time||Recorded|
Takeaways from this session:
Understand the importance of scoping your PER project in advance
Learn the critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete
How to identify those hidden gaps in resources and information and the steps to take to mitigate them