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, […]
Post-Market Literature Surveillance: Systematic Literature Review and Case Study
Post-Market Literature Surveillance: Systematic Literature Review and Case Study Webinar Joining Criterion Edge’s President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In […]
New Guidance Templates for the Post-Market Clinical Follow-Up (PMCF) Plan and PMCF Evaluation Report
Author: Suzanne Broussard The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the […]