Module 16 2022
05/09/2022
Risk management
identifies known and foreseeable hazards.
Post Market Surveillan ce
Uses the CER to understand clinical benefit and safety evaluates the PMCF data to confirm risk control measures are effective Utilises the PMS system for post-production information
Post market clinical follow-up
Clinical Evaluatio n
Risk Mgt
The Organisation for Professionals in Regulatory Affairs
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Post-market clinical follow-up
Relies on risk management to focus areas of follow-up in safety and / or performance Uses the PMS to establish trending thresholds for reporting Uses the CER for end-points or to set the clinical follow-up study design
Clinical Evaluation
Risk Management
PMS
PMCF
The Organisation for Professionals in Regulatory Affairs
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