[FREE WEBINAR] How to Assess Your CER for MDR Readiness, Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review
Get a copy of the slides from this webinar or click to watch the recording. In this first installment of a 2-part webinar series, Criterion Edge will present strategies for […]
Does Your Organization’s Post-Market Clinical Follow-Up (PMCF) Plan Adequately Reflect the Intensity Required in the Clinical Evaluation Report (CER) Under the Newest Medical Device Regulations?
Author: Suzanne Broussard Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible […]
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 […]
