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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

[Ask the Expert] Common Notified Body Review Findings

Virtual Q&A

This session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback.  Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of […]

Free
Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and IVD companies through expert regulatory, scientific, and clinical writing services.
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