What is medical device adverse event monitoring

It applies to the issuance of advisory notices and the control and monitoring of adverse events for medical device products.

Advisory notification:

A precautionary note issued by the Company after delivery of a medical device product in order to provide additional information and/or take measures in the following areas.

Adverse Event:

An adverse event that occurs under normal use of an approved and qualified medical device that causes or may cause human injury, any harmful event unrelated to the intended effect of the use of the medical device.

Responsible for the collection of customer information (including complaints, adverse event information), to give a comprehensive handling report on customer complaints.

Responsible for approving customer complaint reports and determining whether or not to report to the medical device authority/announcement body. Review and determine whether to issue advisory notices or adverse event remedies. Responsible for advisory notices and adverse event remediation.