Latest Past Events

Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation

Webinar

The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association […]

Free

Ask the Writers

Virtual Q&A

Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory […]

Free

How to Establish the Competitive Landscape Within the Scientific Validity Report

Webinar

In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed. […]

Free