How to be great at Management Reviews? [ISO 13485]

Medical Device made Easy Podcast · Feb 15, 2022

When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected to be seen by an auditor when they ask you to show them your Management Review. I will explain: – What is a Management Review – What you should consider when building your Management Review – Which documents are needed – What are the inputs and outputs with examples. I hope this will be helpful for you.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs…