The Summary of Safety and Clinical Performance (SSCP) Provides Valuable Information to Health Care Providers, Patients, and Manufacturers
Author: Suzanne Broussard Is your organization ready to display to the world your medical devices safety and performance record? The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements imposed by manufacturers by […]
[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 […]
