How to implement Vigilance Reporting for MDR and IVDR?

Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about.

Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant.

If you get a serious incident or a Field Safety Corrective Action (FSCA) then below are the steps to follow.

In this episode of the podcast, we will talk about

What to do when there is an incident?

When to report?

Who to report to?

How to report?

Investigation

Field Safety Notice

Significant Changes

Below you will…

The skinny

The skinny isn't ready yet — notes appear once the transcript is processed.