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How to create a QMS compliant to MDR with Stefan Bolleininger
In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi, and Stefan Bolleininger are helping you to create your quality management system with the objective to be compliant to EU MDR 2017/745 or EU IVDR 2017/746 Now even class I devices should have a Quality Management System, but:
Should you apply to ISO 13485?
Is it mandatory?
Do you need to contact a Notified Body or are there other options?
We will help you by providing a step by step understanding on how to get a Quality Management System. We will also help you understand the audit process.
Who is Stefan Bolleininger ?…
The skinny
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