Medical Device Adverse Events and Advisory Notices Reporting Process

The purpose of auditing the Medical Device Adverse Events and Advisory Notices Reporting process is to verify that the organization’s processes ensure that individual device-related adverse events and advisory notices involving medical devices are reported to regulatory authorities within required timeframes.

As a result of the audit of the Medical Device Adverse Events and Advisory Notices Reporting process, objective evidence will show whether the organization has:

• Defined processes to ensure individual device-related adverse events are reported to regulatory authorities as required
• Ensured that advisory notices are reported to regulatory authorities and authorized representatives when necessary; and
• Maintained appropriate records of individual device-related adverse events and advisory notices

Links to other processes include:

• Measurement
• Analysis and Improvement