The Medical Devices Introductory Course 2020

Summary

The Organisation for Professionals in Regulatory Affairs

Recap

Incident (MDD): Device Malfunction or deterioration in characteristics lead to death or et al ….

Serious Incident (MDR): Incident led/might have led/might lead to death/serious deterioration/public health threat

* Adverse Event

Untoward medical occurrence, unintended disease, injury in the context of “clinical investigation”

Corrective Action: Prevent recurrence

Preventive Action: Prevent occurrence

PSR: Similar Incidents with same device where root cause is known

Trend Reporting: Significant increase in: already reportable Incidents, events that are usually not reportable (side-effects)

Post market Surveillance: Proactive

Post market Vigilance: Reactive

The Organisation for Professionals in Regulatory Affairs