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The Step-by-Step recipe to get MDR & IVDR Certified

The Step-by-Step recipe to get MDR & IVDR Certified

For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy. The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device made Easy Podcast

December 21, 2021

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Show Notes

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
  • Certification

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…

Social Media to follow

Episode 159 -  Step by step process to get EU MDR & IVDR Certified

The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Topics

medicaldeviceregulationMEDTECHINDUSTRYregulatoryaffairsISO13485EUMDRMDR2017/745MedicalDeviceIndustryQualityManagementSystemFDAANVISATGAEURegulatoryComplianceAuditsNotifiedBodymeddevicetrainingcertificationbusinesstechnolo