Module 16 2022

05/09/2022

Post-market surveillance

Relies on risk management plan to establish key data points Uses the PMCF to set and monitor trending thresholds Uses the CER to augment data where gaps in knowledge are identified

PMCF

Clinical Evaluation

Risk Mgt

PMS

The Organisation for Professionals in Regulatory Affairs

37

Trending

The Organisation for Professionals in Regulatory Affairs

38

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