Post-Market Literature Surveillance: Systematic Literature Review and Case Study Webinar Joining Criterion Edge's President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic's Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In […]
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 […]
This session's topic: Safety and Performance Measures and Acceptance Criteria for MDR 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 […]
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" […]
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 […]
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 […]
Join us at the ECCMID in Lisbon, Portugal Criterion Edge provides medical and regulatory writing services for the in vitro diagnostics (IVD) industry and will be attending the 32nd European […]
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 […]
Join us at RAPS Euro Convergence in Amsterdam, Netherlands Criterion Edge provides medical and regulatory writing services for the medical device, pharmaceutical, and in vitro diagnostics industries and will be attending RAPS Euro Convergence in Amsterdam, from May 10-12. Our specialists will be on site at the conference ready to meet you and your team […]
