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Post Market Surveillance system, Complaint handling system input to PMS -…
Post Market Surveillance system
CEP
CER
PMSP
PMCFP
Survey
Market Feedback
Management Review
CAPA/Action items
Mgmt Review actions are detailed in PMCFR
Complaint handling system
Survey responses meeting definition of complaint feed into
NC
CAPA
Notifiable CAPA
Notifiable CAPA feeds into PSUR
1 more item...
Risk Management system
Evaluation of Risk Management file feeds into PSUR
Incident reports / trend reporting
Vigilance actions: Incidents, Recalls, Trend Reports Feed into PSUR
Complaints feed into PSUR
PMCFR
PSUR
Literature search feeds into PMCFR, PSUR and CER. Is this referring to the literature search that is done as part of the scheduled CER? Or is this really more like a quarterly literature review and we could justify not doing quarterly related to low risk, established device?
Other PMCF tasks such as PMCF studies, registries, etc, if applicable
Feeds into PMCFR, if applicable
Complaint handling system input to PMS