FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting

Giovanni Di Rienzo Giovanni assessed over 400 design dossiers or technical files of high-risk devices in the cardiovascular, endovascular and neurovascular field, including drug-device combinations, absorbable devices and devices containing animal tissue and has overseen the assessment of many more. 

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful.

🔎 In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?

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