Essentials of European Medical Device Regulatory Affairs
Post Market Surveillance PMS
Surveillance
Vigilance
• Complaints Management • Customer satisfaction surveys • Literature review • User group feedback sessions • PMCF (Post market clinical follow up)
• Serious incidents • Field Safety Corrective actions (FSCA)
Proactive
Reactive
The Organisationfor Professionals inRegulatory Affairs
Post Market Surveillance Lifecycle
The Organisationfor Professionals inRegulatory Affairs
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