The Medical Devices Introductory Course 2020

Vigilance

STEP ONE – THE EVENT

Process starts when anyone in the manufacturer’s organisation becomes aware of the casual relationship between their device and the incident

Information about an event may come from a number of different sources, both internal and external, (such as complaints, PMS data, internal audit, regulatory body and others – PMS !!)

● Define the potential sources and ensure that controls are in place to engage vigilance procedure

● Regardless of the source information must be assessed by the legal manufacturer without delay

● Remember, the clock is ticking…!

Vigilance