Practical Regulatory Affairs 2020 – European Medical Devices
Learn about the new EU Medical Device Regulations and their impact on different medical devices. This course provides practical guidance and real-world examples to help manufacturers comply with the MDR. Suitable for regulatory professionals, engineers, physicians, and project team members.
What you’ll learn
- Learn about the new EU Medical Device Regulations and how it will impact different medical devices.
- Understand how to obtain CE Marking under the Medical Device Regulations.
- 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
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