How Can a Systematic Literature Review (SLR) Help Prevent Common Pitfalls in Meeting the Elementary Requirements of Clinical Evaluation for MEDDEV 2.7/1 revision 4 Clinical Evaluation Report (CER)?
Author: Suzanne Broussard Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 […]
Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers
Author: Suzanne Broussard All medical devices sold in Europe must have a Clinical Evaluation Report (CER), and specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, […]
