Serious incident (MDR definition)

Any incident that directly or indirectly led, might have led or might lead to any of the following: 

• The death of a patient, user or other person, 
• The temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, 
• A serious public health threat. 

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Vigilance

From pre-market product safety to post-market surveillance, we provide integrated vigilance services…