The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER Do you have questions about how to generate, collect, analyze, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you […]
This session's topic: Safety and Performance Measures and Acceptance Criteria Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant? Do […]
This session's topic: Safety and Performance Objectives and Acceptance Criteria for IVDR Do you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are the best methods and practices for identifying acceptance criteria? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant? During this […]
How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation […]
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 […]
Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define safety and performance objectives? What are the biggest pitfalls or "Achille's heels" to watch out for in identifying safety and performance measures? In this webinar, we'll take a deep dive into the best practices to identify relevant […]
Clinical Data for IVD: What is it and How Do I Find It? Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are […]
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 […]
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. […]
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 […]
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 […]
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? […]
