[ISO 13485 Cl, 8.2.3] 

Vigilance is an important clause of the quality management system detailed in ISO 13485. It pertains to the systematic approach to monitoring and assessing the performance and safety of medical devices after they are available on the market.

Conversely, vigilance also involves the swift reporting and examination of any adverse events or incidents that arise from the use of a medical device. This process includes promptly informing the appropriate regulatory bodies and taking necessary corrective and preventive measures to reduce any related risks. ( This is mainly applicable in EU)