Ask the Expert: Clinical Evaluation Report Critical Concepts
Ask the Expert: Clinical Evaluation Report Template and Critical Concepts This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, […]
CER Critical Concepts
Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance […]
IVD Deep Dive Series Part 2
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 […]