What you’ll learn
- Regulatory Changes from MDD to MDR
- Timelines to implement MDR
Requirements
- No prior knowledge is needed
Description
This is a basic course on European regulations. You will learn how to smoothly transition from MDD to MDR. The course is broadly divided into 5 modules covering various topics like regulatory changes, roles of Stakeholders, economic operators, Medical Device classification, CE mark, Clinical evaluation, Post Market Surveillance, UDI and EUDAMED. The course includes carefully designed quizzes and assignments for self-assessment.
Who this course is for:
- For regulatory professionals interested in learning the EU regulations
- For students interested in switching careers
- For anyone who wishes to learn about the MDD to MDR change
About the trainers/speakers
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- Monir El Azzouzi – Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, Monir decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses …
Approximate course length
- Self-paced
