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 […]
ATE: The Role of RA in the Clinical and Performance Evaluation Process

Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process Regulatory Affairs is poised to play a critical role in supporting the current MDR and […]
The Role of RA in the Clinical and Performance Evaluation Process

The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success Regulatory Affairs plays a critical role in supporting the current MDR and […]