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Post-Market Surveillance
Setting up your PMS plan and PSUR
Create a PMS Plan
Define the post-market data sources, methods, responsibilities, and review cadence.
Create a PMCF Plan
Plan clinical follow-up activities that address safety, performance, and uncertainty.
Understand PMS reports and PSURs
Know why the reporting route depends on device type and classification.
Use complaints, feedback, sales, and service data
Turn routine business data into useful post-market surveillance inputs.