The Step-by-Step recipe to get MDR & IVDR Certified
For this episode, I wanted to show you how it is possible to plan your MDR & IVDR certification. This is a question that people ask me when they reach out. “What should I do to get ready for MDR or IVDR certification?”
So here we will talk about:
- Quality Management System
- Technical Documentation
- Clinical Evaluation
- Audit readiness
- Audit completion
I hope this will help you in your process. In case you need support don’t hesitate to reach out. My team and I are ready to help 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…