How to be great at Management Reviews? [ISO 13485]
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. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…