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About Course
A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations.
The EU Medical Device Regulations (MDR 2017/745) represents the biggest change to medical device legislation in Europe for over 20 years. The MDR affects all medical device manufacturers (and others!) wanting to sell devices in the EU. This course focuses on the practical application of the MDR, using real-world examples and exercises to help you understand not only what the Regulations mean, but what we need to do to comply with them.
Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to transition to the MDR.
Course Content
Introduction and Background
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00:54
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01:56
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00:50
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01:49
Directives to Regulations
EU Regulatory Pathway MDR 2017/745
Medical Device Assessment
Device Classification
Conformity Assessment Route
Quality Management System
Annex II Technical Documentation
Post-Market Surveillance (Annex III Techincal Documentation)
Declaration of Conformity and CE Marking
Final Updates and Timelines
Student Ratings & Reviews
Finished
Too much repetition, but a few parts were worth the time.
The volume of the explaining is poor . We have to listen much more carefully to not miss any word or point
The transcripts contain a LOT of mistakes, which makes it very hard to understand.
Moreover, I found the explanation of the MDR Enforces poor.
Moreover, I found the explanation of the MDR Enforces poor.
Rechtschreibfehler, sehr basic, schlechte Folien
Not very engaging, but it covered some important fundamentals.
The course felt outdated, though a couple of topics were informative.
I found it hard to follow, but a few sections were useful.
Valuable insights, though I expected more from the course overall.
Decent information, but it felt repetitive in parts.
Very basis information
It was okay, but I felt it could have been more comprehensive.
Clear explanations, but it didn’t go into enough detail for my needs.
I was interested in the IVDD, the description of the course didn't mention it will focus only on the MDR.
Perfect for the upcoming deadline. Very high level course not detail specific. For beginners rather.
Interesting material, but the course felt too long.
Good overview, but I expected more advanced content.
In depth topics should be covered.
Solid foundation, but lacked detail in key areas.
Useful, though the delivery could be more engaging.