Essentials of European Medical Device Regulatory Affairs

Guidance

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

The Organisationfor Professionals inRegulatory Affairs

Module 6

The Post Market Phase: • Post Market Surveillance • PMCF • Vigilance • FSCA (Field Safety Corrective Action) • FSN (Field Safety Notice)

The Organisationfor Professionals inRegulatory Affairs

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