Module 16 2022
05/09/2022
Post Market Surveillance
PMCF
Clinical Evaluat ion
Risk Mgt
Post-market clinical follow-up
Benefit and Risks
Clinical Evaluation
PMS
Post Market Surveillance
Clinical Evaluation
Post-market clinical follow-up
Clinical Evaluation
Risk Management
PMS
Risk Mgt
PMCF
The Organisation for Professionals in Regulatory Affairs
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Clinical evaluation
identifies the risks uses the PMS to update the benefit-risk and; evaluates the PMCF data to confirm performance has been achieved or safety has not been compromised
Post Market Surveillance
Post market clinical follow-up
Benefit and Risks
Clinical Evaluation
The Organisation for Professionals in Regulatory Affairs
34
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