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In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is: “How to get ISO 13485 certified?”

As Easy Medical Device is a consulting agency helping Medical Device manufacturers to place compliant medical devices on the market, most of our clients have no experience in the Medical Device Regulations.

So in this video, I will answer this question.

AGENDA

• What is ISO 13485?

Don’t hesitate to reach Easy Medical Device to get some support on your QMS certification process. Or any other Quality and/or Regulatory affairs question.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, Bausch and Lomb or BBraun Medical, 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, Podcast, Online courses…

• 5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/

The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi