With the implementation of IVDR requirements and 2022 deadline approaching, 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).
Key Takeaways: •The importance of scoping your PER project in advance •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
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers 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.
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