Practical Regulatory Affairs 2020 – European Medical Devices
What you’ll learn
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Learn about the new EU Medical Device Regulations and how it will impact different medical devices.
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Understand how to obtain CE Marking under the Medical Device Regulations.
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Complete real-world examples and exercises to apply the Medical Device Regulations to mock medical devices.
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.
Who this course is for:
- Junior Regulatory Affairs professionals
- Engineers with medical device experience
- Physicians/Professors with device ideas
- Medical device project team members
10 reviews for Practical Regulatory Affairs 2020 – European Medical Devices
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Original price was: $39.99.$18.99Current price is: $18.99.
Alyssa Ng Sook Kei –
Great course! I have gained good overall understanding of MDR 2017/745. Thank you!
Wendy D. Smith –
Had some difficulty understanding instructor’s accent, especially pronunciation of certain words.
Ramamohan Reddy Korivi –
Really useful to understand EU regulatory pathway!!!!
Deepak Kumar –
Difficult for to understand the speakers pronunciation.
Suparna Das –
I liked this course. It is short but impactful.
Cidye Murielle Seumen Njonfang –
The teacher explains very clearly. For non-native speakers, it might be a bit complicated because of the accent/pronunciation
Muhammad Farooq –
Please correct the spellings in transcripts.
Thanks
Thelma Anozie –
Well delivered course!
Yeukai Faith MUKONDWA –
Highly detailed and very interesting.
Eric Huang –
Clear description. But limited contents, could be more solid.