Companies bringing medical devices on the market are obliged to have an appropriate system of vigilance and post market surveillance (PMS) in place.
QbD help you to set up your system.
Incidents to be reported:
- Any malfunction, failure or deterioration in the characteristics or performance of a device
- Any inadequacy in labelling or the Instructions for Use (IFU)
– which directly or indirectly lead to or may have led to the death of a patient or user or of another person, or lead to a serious deterioration in their state of health.
- Any technical or medical reason which may have lead to a batch recall of other similar devices.
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