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MDR
Post-Market Surveillance
PMS obligations, vigilance reporting, PMCF studies, and periodic safety update reports.
- 1
Post-Market Surveillance System
PMS plan requirements, data sources, and the proactive surveillance obligation.
12 minRequires: QMS Fundamentals under the MDR - 2
Vigilance and Incident Reporting
Serious incidents, field safety corrective actions, and reporting timelines.
14 minRequires: Post-Market Surveillance System - 3
Post-Market Clinical Follow-up
PMCF plans, study design, PMCF evaluation reports, and integration with clinical evaluation.
16 minRequires: Post-Market Surveillance System, Clinical Evaluation - 4
Periodic Safety Update Reports
PSUR content, frequency requirements by device class, and trend analysis.
12 minRequires: Post-Market Surveillance System - 5
Trend and Signal Detection
Statistical methods, complaint analysis, and when to escalate findings.
14 minRequires: Periodic Safety Update Reports