IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we'll present strategies to keep you and your team on track and help assess your own […]
Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of […]
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 […]
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). […]
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