Scoping Your MDR and IVDR Writing Projects - The Forgotten Step In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? […]
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 […]
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 […]
